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 (b)(6) 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 the issue was confirmed during qc testing in-house.Intermittent sensor led failures were detected during this test.The investigation shows the system correctly disabled the sensor due to performance failure and the system's self-test functions are working normally.D8 was this device serviced by a third party? no.D9 device available for evaluation? yes, device received on 10/15/2020.H3.Device evaluated by manufacturer? yes.H6.Health effect - clinical code updated to 4582.H6.Health effect -impact code updated to 2199.H6.Medical device problem code updated to 1559.H6.Component code updated to 510.H6.Type of investigation updated to 4111 and 10.H6.Investigation findings updated to 4203.H6.Investigation conclusions updated to 4307.
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Search Alerts/Recalls
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