This report is being submitted retrospectively as part of internal review.Investigation of the returned sensor did not reveal any malfunction as it passed all functional tests and visual inspection.A review of the in-vivo glucose data was not possible as user had not synced any glucose data to data management system (dms), which is a cloud platform for eversense systems.User reported that they had infection at insertion site ((b)(4)) and possibly, this affected the sensor performance.The mdr report for (b)(4) (3009862700-2023-00294) was submitted separately.
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Senseonics was made aware of an incident where the user received an early sensor replacement alert resulting in early sensor removal.The user received the alert on (b)(6) 2023, on day 57 of sensor life.Although this incident did not lead to any adverse events, the user had infection at insertion site reported around the same time.This was documented as a separate case.
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