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Model Number 101967-931 |
Device Problems
Premature End-of-Life Indicator (1480); Optical Problem (3001)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/03/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This report is being submitted retrospectively as part of internal review.The returned sensor was tested in-house, however, the testing results did not indicate any malfunction of the sensor.The failure mode (sensor performance deviation) could not be reproduced during the returned product analysis testing.This may occur in some instances where the failure mode that presents itself in the body is not reproduced in the lab.Further analysis of the in vivo glucose data shows that the rate of change in the glucose values frequently exceeded 5mg/dl/min.This noise is a probable cause of the failure.The investigation showed the system correctly disabled the sensor due to performance failure and the system's self-test functions are working normally.
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Event Description
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On oct.3, 2023, senseonics was made aware of an incident where the user received an early sensor replacement alert resulting in an early sensor removal.
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Search Alerts/Recalls
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