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 07/08/2020 |
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 triggered a true led disconnect alarm as it was determined the sensor led would not light up and the led during the qc test experienced an intermittent crash.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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