Model Number 102096-67A |
Device Problem
Device Sensing Problem (2917)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/23/2020 |
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) 2021, senseonics was made aware of an incident where user experienced no sensor detected alerts resulting in an early sensor removal.
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Manufacturer Narrative
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The rma was authorized but not received so no further confirmation or investigation of the complaint is possible.H3.Device evaluated by manufacturer? no, not returned to manufacturer.H6.Type of investigation updated to 4114.H6.Investigation findings updated to 3221.H6.Investigation conclusions updated to 67.
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Search Alerts/Recalls
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