Model Number 102096-67A |
Device Problem
Failure to Sense (1559)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/16/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
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Event Description
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On july 18th 2020,senseonics was made aware of an incident where user received an early sensor replacement alert resulting in an early sensor removal.
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Manufacturer Narrative
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The sensor was investigated, and customer complaint was confirmed via in-vivo data review.The absence of communication of the sensor during the explant qc test coupled with the in-vivo data confirm that the sensor has a broken asic.The investigation shows the system correctly disabled the sensor due to performance failure and the system's self-test functions are working normally.
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Search Alerts/Recalls
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