Eversense Safety Information

Eversense E3 CGM System Safety Information

Indications for Use

The Eversense® E3 Continuous Glucose Monitoring (CGM) System is indicated for continually measuring glucose levels for up to 180 days in persons with diabetes age 18 and older.The system is indicated for use to replace fingerstick blood glucose measurements for diabetes treatment decisions. The system is intended to

  • Provide real-time glucose readings.
  • Provide glucose trend information.
  • Provide alerts for the detection and prediction of episodes of low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia).
  • Aid in the management of diabetes

The system is a prescription device. Historical data from the system can be interpreted to aid in providing therapy adjustments. These adjustments should be based on patterns and trends seen over time.

The system is intended for single patient use.

MRI Safety Information

A patient with this device can be safely scanned in a horizontal, closed bore MR scanner meeting the following conditions

  • Static magnetic field of 1.5T or 3.0T.
  • Maximum spatial field gradient of 1900 gauss/cm (≤ 19 T/m).
  • Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4 W/kg (First Level Controlled Operating Mode) for 15 minutes of continuous scanning, or SAR of 2 W/kg for 30 minutes of continuous scanning

Under the scan conditions defined above, non-clinical testing results indicate the Eversense E3 Sensor is expected to produce a maximum temperature rise of less than 5.4 °C. In non-clinical testing, the image artifact caused by the device extends approximately 72 mm (2.83 inches) from the Eversense E3 Sensor when imaged with a gradient echo pulse sequence and a 3T MR system. The Eversense E3 Sensor has not been tested in MR systems that do not meet the conditions above. Exposing the Eversense E3 Sensor to MRI conditions which are outside of the conditions outlined above can cause potential complications such as device migration, heating and tissue damage or erosion through the skin. The Eversense E3 Smart Transmitter is MR Unsafe and MUST BE REMOVED before undergoing an MRI procedure. Before you undergo an MRI procedure, tell the MRI staff that you have an Eversense E3 Sensor and Smart Transmitter, and consult with the health care provider who inserted your sensor.

For the most updated version of the Eversense E3 CGM System labeling, visit https://global.eversensediabetes.com/. You will receive an International Implant Card from your health care provider with each sensor insertion. Keep this card in your wallet as a reference

Contraindications

The smart transmitter is incompatible with magnetic resonance imaging (MRI) procedures. The smart transmitter is MR Unsafe and MUST BE REMOVED before undergoing an MRI (magnetic resonance imaging) procedure. For information on the sensor, please see MRI Safety Information.

The system is contraindicated in people for whom dexamethasone or dexamethasone acetate may be contraindicated.

Mannitol or sorbitol, when administered intravenously, or as a component of an irrigation solution or peritoneal dialysis solution, may increase blood mannitol or sorbitol concentrations and cause falsely elevated readings of your sensor glucose results. Sorbitol is used in some artificial sweeteners, and concentration levels from typical dietary intake do not impact sensor glucose results

Jailbroken Devices

DO NOT use the Eversense Apps on jailbroken iPhones or iPods. Jailbroken devices do not provide an acceptable level of security for the user and are not approved for use by Senseonics.

Broken Screen or Button

If the screen of your mobile device is broken, or the buttons do not work, then you may not be able to use your Eversense E3 System and you may miss low or high glucose events.

Device Modifications

DO NOT modify the Eversense E3 CGM System for use with products, accessories, or peripheral equipment not furnished or approved in writing by Senseonics. Unauthorized modifications void your transmitter warranty and may impact system performance.

Treatment Decisions

Before making a treatment decision, you should take into account the sensor glucose value, the trend graph, the trend arrow and any alerts from the Eversense E3 CGM System. If no trend arrow is displayed, the system does not have enough data to display direction and rate of change. You should not make a treatment decision based solely on the sensor glucose value

Risk and Side Effects

The glucose alerts and notifications will not audibly notify you when the sound on the mobile device is turned off. If the system cannot display a glucose value, it also cannot provide glucose alerts. If you are unable to feel the vibration of the smart transmitter you may not notice the alerts. You may need medical attention in the event that you have high or low glucose and are unaware of it. The system’s calculated glucose can be slightly different from your blood glucose meter. This may cause an alert to activate at a different time than it would have if the system’s values always matched the blood glucose meter values

If you do not test your glucose with a blood glucose meter when your symptoms are not consistent with the sensor glucose readings, you may miss a high or low glucose event.

Treatment decisions should be made based on a review of the following: a sensor glucose value, trend arrow, recent glucose trend graph, and system alerts/notifications. You should not make a treatment decision unless you have considered all this information.

Be sure you talk with your health care provider about insulin action, so you understand how its impact on your glucose may factor into your treatment decisions.

The sensor is inserted by making a small incision and placing it under the skin. The implantation may cause infection, pain, skin irritation, bruising, skin discoloration or atrophy. Dizziness, fainting and nausea were reported in small number during clinical studies, as were instances of the sensor breaking or not being removed on first attempt. Additionally, the adhesive may cause a reaction or skin irritation. Any medical issue related to the procedure or use of the device should be reported to your health care provider. The sensor will require an additional removal procedure at the end of sensor life

Benefits and Risks

Continuous glucose monitoring aids in the management of diabetes and glucose control, which can improve your quality of life. Best results are achieved when you are fully informed about the risks and benefits, insertion procedure, follow-up requirements, and self-care responsibilities. You should not have the sensor inserted if you cannot properly operate the CGM System.

Failure to use the Eversense E3 CGM System in accordance with the instructions for use may result in you missing a hypoglycemic or hyperglycemic glucose event, which may result in injury. The sensor has a silicone ring that contains a small amount of an anti-inflammatory drug (dexamethasone acetate). It has not been determined whether the risks associated with injectable dexamethasone acetate apply to the dexamethasone acetate elution ring inside the sensor. The elution ring releases a small amount of dexamethasone acetate when the sensor comes in contact with body fluids and serves to minimize the body’s inflammatory response to the inserted sensor. Dexamethasone acetate in the ring may also cause other adverse events not previously seen with the injectable form. For a listing of potentially adverse effects related to dexamethasone acetate, contact your health care provider.

Unauthorized modifications of the equipment, improperly accessing information within it or “jailbreaking” your system, and taking any other unauthorized actions may cause the CGM system to malfunction and may put you at risk. Unauthorized modification of the equipment is not permitted and voids your warranty.

Any serious incident that has occurred related to the use of the device should be reported to the manufacturer and the competent authority of your Member State.

Warnings

  • The Eversense E3 CGM System has not been tested using insertion sites other than the upper arm.
  • If at any time your symptoms are not consistent with the sensor glucose readings, you should test your glucose with a blood glucose meter.
  • Before making a treatment decision, you should take into account the sensor glucose value, the trend graph, the trend arrow and any alerts from the Eversense E3 CGM System. If no trend arrow is displayed, the system does not have enough data to display direction and rate of change. You should not make a treatment decision based solely on the sensor glucose value.
  • Please review this User Guide with your health care provider. For additional Eversense E3 product questions and troubleshooting issues, contact Customer Support toll free in the US at 844-SENSE4U (844-736-7348). Outside the US, call your local distributor or visit https://global.eversensediabetes.com to locate your local distributor.
  • Always calibrate the system using only a fingerstick blood sample. DO NOT use an alternative site (such as forearm or palm) blood glucose reading to calibrate the system.
  • DO NOT insert your infusion set or inject insulin within 4 in (10.16 cm) of the sensor site. If the insulin delivery site is within 4 in (10.16 cm) of the sensor site, it may interfere with sensor glucose readings and can cause inaccurate glucose readings.
  • Always follow your health care provider’s instructions for care after the sensor insertion or removal. Contact your health care provider if any of the following events occur: – You have pain, redness, or swelling at the incision site(s) later than 5 days after the sensor insertion or removal, or if the incision has not healed within 5 to 7 days.
  • If your sensor glucose is very low (below 40 mg/dL) or very high (above 400 mg/dL), you should perform a fingerstick blood glucose test prior to making a treatment decision.
  • The Eversense E3 CGM System requires calibration in order to provide accurate readings. You should not use CGM readings to make treatment decisions unless you have followed the instructions for daily calibration.
  • The Eversense E3 CGM System will not provide readings during the 24-hour Warm-Up Phase and until a second calibration is successful during the Initialization Phase. During this time, you should monitor your glucose using a home blood glucose monitor.
  • Certain conditions and alerts will prevent glucose data from being displayed. During these times, you should use a home blood glucose monitor to make treatment decisions. You should carefully read the Alerts and Notifications section of their Eversense E3 CGM System User Guide to understand these conditions.
  • The glucose alerts and notifications will not audibly notify you when the sound on your mobile device is turned off. If the system cannot display a glucose value, it also cannot provide glucose alerts. If you are unable to feel the vibration of the smart transmitter you may not notice the alerts.
  • When the smart transmitter is not worn over the sensor, such as during charging, the Eversense E3 CGM System will not provide alerts and notifications on the mobile device or through vibration alerts from the smart transmitter

Cautions

  • DO NOT exchange smart transmitters with another person. Each smart transmitter can be linked to only one sensor at a time. The system is to be used by one person in the home environment.
  • The following medical therapies or procedures may cause permanent damage to the sensor particularly if used in close proximity to the device: – Lithotripsy – The use of lithotripsy is not recommended for people who have an inserted sensor because the effects are unknown. – Diathermy – DO NOT use diathermy on people who have an inserted sensor. Energy from the diathermy can transfer through the sensor and cause tissue damage in the insertion area. – Electrocautery – The use of electrocautery near the inserted sensor may damage the device. DO NOT use electrocautery near the sensor.
  • Steroid use – It has not been determined whether the risks usually associated with injectable dexamethasone acetate apply to the use of this dexamethasone acetate elution ring, a highly localized, controlled-release device. The dexamethasone acetate ring could cause other adverse events not listed or previously seen.
  • DO NOT wear the smart transmitter during medical x-rays or computed tomography (CT) scans. To avoid interference with results, remove the smart transmitter before undergoing medical x-ray or CT scans. Make sure your health care provider knows about your smart transmitter.
  • The sensor and smart transmitter should be linked the day of insertion. Failure to link the sensor and smart transmitter could result in a delay in receiving glucose readings.
  • If the sensor, insertion site or smart transmitter feels warm, remove the smart transmitter immediately and contact your health care provider for further advice. A warm sensor could mean there is an infection or a sensor malfunction.
  • DO NOT attempt to use the Eversense App while operating a motor vehicle.
  • You should not receive massage therapy near the inserted sensor site. Massage therapy near the sensor site could cause discomfort or skin irritation.
  • Use only the AC power adapter and USB cable provided with the smart transmitter when charging the smart transmitter battery. Use of another power supply could damage the smart transmitter, not allowing glucose readings to be received properly, and could result in voiding your warranty.
  • If you have any concerns about allergic reaction to adhesive products containing silicone, contact your health care provider prior to use. Discard the Eversense adhesive patch after each use of up to 24 hours.
  • DO NOT change the unit of measurement unless you have discussed it with your health care provider. Using the incorrect unit of measure could result in missing a high or low glucose event.
  • Entering incorrect blood glucose values for calibration can result in inaccurate sensor glucose readings, which may result in you missing a high or low glucose event.
  • Follow your health care provider’s recommendation for setting your glucose alerts. Incorrectly setting your glucose alerts can result in you missing a high or low glucose event.
  • Pay attention to the glucose alerts the system provides. Failure to appropriately respond to an alert might result in you missing a high or low glucose event.
  • The Eversense NOW Remote Monitoring App does not replace the monitoring regimen as directed by your health care provider.
  • The Eversense E3 CGM System has not been tested in the following populations: women who are pregnant or nursing, people under the age of 18, critically ill or hospitalized patients, people receiving immunosuppressant therapy, chemotherapy or anti-coagulant therapy, those with another active implantable device, e.g., an implantable defibrillator (passive implants are allowed, e.g., cardiac stents), those with known allergies to or using systemic glucocorticoids (excluding topical, optical or nasal, but including inhaled). The system’s accuracy hasn’t been tested in these populations, and sensor glucose readings may be inaccurate, resulting in missing a severe low or high glucose event.
  • The Apple Watch is a secondary display of Eversense E3 CGM data and should not be used in place of the primary Eversense E3 CGM display.

Eversense Data Management Software (DMS) Program

Intended Use

The Eversense DMS Program is a web-based application that enables patients, caregivers, and health care professionals to view and analyze glucose data that has been transmitted from the Eversense E3 Smart Transmitter or the Eversense CGM System Mobile App. This program is offered at no cost to users of the Eversense E3 CGM System. To learn about the Eversense DMS Program, go to https://global.eversensediabetes.com/. When you create and register your account during the installation of the Eversense CGM Mobile App, an Eversense DMS account is automatically created for you. The Eversense NOW App User Guide has more information on how to remotely view glucose data from the Eversense E3 CGM System

IMPORTANT: EVERSENSE E3 DATA MANAGEMENT SYSTEM DOES NOT PROVIDE MEDICAL ADVICE. CHANGES TO YOUR TREATMENT PLAN SHOULD ONLY BE MADE BY YOUR HEALTH CARE TEAM.

MKT-001531 Rev 1

Eversense XL CGM System Safety Information

Indications for Use

The Eversense XL CGM System is indicated for continually measuring interstitial fluid glucose levels in adults (18 years and older) with diabetes for the operating life of the sensor. The system is intended to:

  • Aid in the management of diabetes.
  • Provide real-time glucose readings.
  • Provide glucose trend information.
  • Provide alerts for the detection and prediction of episodes of low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia).

Historical data from the system can be interpreted to aid in providing therapy adjustments. These adjustments should be based on patterns and trends seen over time.

The system is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home blood glucose monitoring devices.

MRI Safety Information

A patient with this device can be safely scanned in a horizontal, closed bore MR scanner meeting the following conditions:

  • Static magnetic field of 1.5T or 3.0T
  • Maximum spatial field gradient of 1900 gauss/cm (≤19 T/m)
  • Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4 W/kg (First Level Controlled Operating Mode) for 15 minutes of continuous scanning, or SAR of 2 W/kg for 30 minutes of continuous scanning.

Under the scan conditions defined above, non-clinical testing results indicate the Eversense Sensor is expected to produce a maximum temperature rise of less than 5.4 °C. In non-clinical testing, the image artifact caused by the device extends approximately 2.83 inches (72 mm) from the Eversense Sensor when imaged with a gradient echo pulse sequence and a 3T MR system. The Eversense Sensor has not been tested in MR systems that do not meet the conditions above. Exposing the Eversense Sensor to MRI conditions which are outside of the conditions outlined above can cause potential complications such as device migration, heating and tissue damage or erosion through the skin. The Eversense Smart Transmitter is MR Unsafe and MUST BE REMOVED before undergoing an MRI procedure. Before you undergo an MRI procedure, tell the MRI staff that you have an Eversense Sensor and Smart Transmitter. You may wish to share this information with the MRI staff. For the most updated version of the Eversense CGM System labeling, visit eversensediabetes.com.

Contraindications

The smart transmitter is incompatible with magnetic resonance imaging (MRI) procedures. Patients should not undergo an MRI procedure when wearing the smart transmitter. For information on the sensor, please see MRI Safety Information.

  • The system is contraindicated in people for whom dexamethasone or dexamethasone acetate may be contraindicated.
  • Therapeutics products such as mannitol intravenous and irrigation solutions may increase blood mannitol concentrations and cause falsely elevated readings of sensor glucose results.

Jailbroken Devices

DO NOT use the Eversense apps on jailbroken iPhones or iPods. Jailbroken devices do not provide an acceptable level of security and accuracy for the user and are not approved for use by Senseonics.

Broken Screen or Button

If the screen of your mobile device is broken, or the buttons do not work, then you may not be able to use your Eversense System and you may miss low or high glucose events.

Risks and Side Effects

The glucose alerts and notifications will not audibly notify the user when the sound on your mobile device is turned off. If the system cannot display a glucose value, it also cannot provide glucose alerts. If you are unable to feel the vibration of the smart transmitter you may not notice the alerts. The system’s calculated glucose can be slightly different from your blood glucose meter. This may cause an alert to activate at a different time than it would have if the system’s values always matched the blood glucose meter values.

If you do not take frequent blood glucose measurements and miss an alert, you may not be aware of high or low glucose levels. You may need medical attention in the event that you have high or low glucose and are unaware of it.

If you do not test your glucose with a blood glucose meter when you have symptoms of a low or high blood glucose level OR when your symptoms are not consistent with the sensor glucose readings, you may miss a high or low glucose event. Treatment decisions made without confirming with a blood glucose meter check may result in a high or low glucose event, since blood glucose values can be slightly different than your sensor glucose values measured in interstitial fluid.

The sensor is inserted by making a small incision and placing it under the skin. The implantation may cause infection, pain, skin irritation, bruising, skin discoloration or atrophy. Dizziness, fainting and nausea were reported in small number during clinical studies, as were instances of the sensor breaking or not being removed on first attempt. Additionally, the adhesive may cause a reaction or skin irritation. Any medical issue related to the procedure or use of the device should be reported to your health care provider.

Warnings

  • If at any time you have symptoms of a low or high blood glucose level OR if your symptoms are not consistent with the sensor glucose readings, you should test your glucose with a blood glucose meter.
  • Always test your glucose with your blood glucose meter before making a treatment decision.
  • If your smart transmitter is damaged or cracked, DO NOT use, as this could create an electrical safety hazard or malfunction, and could result in electrical shock.
  • Close contact with direct EMI may interfere with the smart transmitter’s ability to send data to your mobile device. Move away from the source of EMI and check that your mobile device is connected to your smart transmitter.
  • High doses of aspirin (over 2000 mg), such as for chronic treatment of inflammatory conditions (e.g., rheumatoid arthritis), may falsely lower Sensor glucose readings.
  • Until it has healed, always cover the insertion site with a sterile bandage before placing the smart transmitter adhesive over the sensor. Failure to do so could result in infection at the insertion site.
  • Please review the Eversense CGM System User Guide with your health care provider. For additional Eversense product questions and troubleshooting issues, contact Customer Support toll free in the US at 844-SENSE4U (844-736-7348). Outside the US, call your local distributor or visit www.eversensediabetes.com to locate your local distributor.
  • Always calibrate the system using only a fingerstick blood sample. DO NOT use an alternative site (such as forearm or palm) blood glucose reading to calibrate the system.
  • DO NOT insert your infusion set within 10.16 cm (4 in) of the sensor site. If the insulin delivery site is within 10.16 cm (4 in) of the sensor site, it may interfere with sensor glucose readings and can cause inaccurate glucose readings.

Always follow your physician’s instructions for care after the sensor insertion or removal. Contact your physician if any of the following events occur:

  • You have pain, redness, or swelling at the incision site(s) later than 5 days after the sensor insertion or removal, or if the incision has not healed within 5 to 7 days.

Cautions

  • DO NOT exchange smart transmitters with another person. Each smart transmitter can be linked to only one sensor at a time.
  • The following medical therapies or procedures may cause permanent damage to the sensor particularly if used in close proximity to the device:
  • Lithotripsy – The use of lithotripsy is not recommended for people who have an inserted sensor because the effects are unknown.
  • Diathermy – DO NOT use diathermy on people who have an inserted sensor. Energy from the diathermy can transfer through the sensor and cause tissue damage in the insertion area.
  • Electrocautery – The use of electrocautery near the inserted sensor may damage the device. DO NOT use electrocautery near the sensor.
  • DO NOT wear the smart transmitter during medical x-rays or computed tomography (CT) scans. To avoid interference with results, remove the smart transmitter before undergoing medical x-ray or CT scans. Make sure your physician knows about your smart transmitter.
  • The sensor and smart transmitter should be linked the day of insertion. Failure to link the sensor and smart transmitter could result in a delay in receiving glucose readings.
  • Steroid use – It has not been determined whether the risks usually associated with injectable dexamethasone acetate apply to the use of this dexamethasone acetate elution ring, a highly localized, controlled-release device. The dexamethasone acetate ring could cause other adverse events not listed or previously seen.
  • If the sensor or smart transmitter feels warm, remove the smart transmitter immediately and contact your physician for further advice. A warm sensor could mean there is an infection or a sensor malfunction.
  • Remove the smart transmitter from your arm before charging the smart transmitter battery. Failure to remove the smart transmitter while it is charging could result in electrical shock.
  • DO NOT attempt to use the Eversense App while operating a motor vehicle.
  • You should not receive massage therapy near the inserted sensor site. Massage therapy near the sensor site could cause discomfort or skin irritation.
  • Use only the AC power adapter and USB cable provided with the smart transmitter when charging the smart transmitter battery. Use of another power supply could damage the smart transmitter, not allowing glucose readings to be received properly, and could result in voiding your warranty.
  • If you have any concerns about allergic reaction to silicones, contact your physician prior to use.
  • Discard the patch after 24 hours of use.
  • The Eversense CGM System has not been tested in the following populations: women who are pregnant or nursing, people under the age of 18, critically ill or hospitalized patients, people receiving immunosuppressant therapy, chemotherapy or anti-coagulant therapy, those with another active implantable device, e.g., an implantable defibrillator (passive implants are allowed, e.g., cardiac stents), those with known allergies to or using systemic glucocorticoids (excluding topical, optical or nasal, but including inhaled).
  • The Apple Watch is a secondary display of Eversense CGM data and should not be used in place of the primary Eversense CGM display.

Eversense DMS

Intended Use

The Eversense Data Management System (DMS) is intended for use as an accessory to compatible Eversense CGM products. It is a web based application that may be used to view, analyze, and store glucose information from your Eversense CGM System. The DMS is designed to view the data from your Eversense CGM System in a useful, easy to read format to help you in the management of your diabetes.

You can sync your CGM data wirelessly to the Eversense DMS using the Share My Data feature on the Eversense mobile app. PC users can also upload smart transmitter data via the USB cable provided with your Eversense CGM System.

Note:

  • You will be uploading the same data whether you sync from the mobile app or use the USB cable.
  • For more information on the Eversense CGM System, visit www.eversensediabetes.com.
  • For further information on compatible browsers and browser versions please visit eversensediabetes.com.
  • Uploading from the smart transmitter using the USB cable is only supported on PCs.

IMPORTANT: EVERSENSE DATA MANAGEMENT SYSTEM DOES NOT PROVIDE MEDICAL ADVICE. DO NOT MAKE TREATMENT DECISIONS WITHOUT CONSULTING WITH YOUR HEALTH CARE TEAM.

MKT-001113 Rev 2