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 02/23/2024 |
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 february 26, 2024, senseonics was made aware of an incident where the user received an early sensor replacement alert resulting in an early sensor replacement.
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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.As part of resolution, the rma was authorized to offer the user a sensor replacement.B4.Date of this report 13 may 2024.G3.Date received by the manufacturer? 12 may 2024.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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