Model Number 101967-950 |
Device Problem
Failure to Sense (1559)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/28/2024 |
Event Type
malfunction
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Event Description
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On february 29, 2024, 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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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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Manufacturer Narrative
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The rma was authorized but not received, thus no confirmation or investigation of the complaint was possible.Date of this report 21 may 2024.Primary unique device identifier (udi) number updated to (b)(4).Date received by the manufacturer? 20 may 2024.Device evaluated by manufacturer? no.Type of investigation updated to 4114.Investigation findings updated to 3221.H6.Investigation conclusions updated to 67.
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Search Alerts/Recalls
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