eversense E3 - 2. Benefits and Risks

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Eversense E3 CGM User Guide
2
2. Benets and Risks
This section describes the benets, expectations and risks associated with using the Eversense
E3 CGM System. Additional safety information is available at https://ec.europa.eu/tools/eudamed
(European database on medical devices - EUDAMED) in the Eversense E3 CGM System Summary
of Safety and Performance (SSCP), or upon request to Customer Support. The SSCP is linked to the
Eversense E3 CGM system component Basic UDI-DI numbers that are listed on the back cover of
this Instruction Manual.
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.
The CGM System measures glucose in interstitial fluid (ISF) between the body’s cells. Physiologic dierences between
ISF and blood from a fingerstick may result in dierences in glucose measurements. These dierences are especially
evident during times of rapid change in blood glucose (e.g., after eating, dosing insulin, or exercising), and for some
people, during the first several days after insertion due to inflammation that may result from the insertion procedure.
Glucose levels in ISF lag behind glucose levels in blood by several minutes.
IMPORTANT: If your symptoms do not match the glucose alerts and readings from the Eversense E3 CGM
System, a fingerstick blood glucose check with a home blood glucose meter should be performed prior to making
treatment decisions.
Failure to use the Eversense E3 CGM System in accordance with the instructions for use may result in you missing
a hypoglycaemic or hyperglycaemic glucose event, which may result in injury.