Model Number 101967-950 |
Device Problem
Imprecision (1307)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/10/2024 |
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 (b)(6)2023, senseonics was made aware of an incident where a user experienced sensor inaccuracy which led to an early sensor removal.
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Event Description
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On february 14, 2024, senseonics was made aware of an incident where a user experienced sensor inaccuracy which led to an early sensor removal.
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Manufacturer Narrative
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B4.Date of this report updated to 15 march 2024.B5.Describe event or problem updated.
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Manufacturer Narrative
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The sensor replacement alert was first presented to the user on (b)(6) 2024, day 122 post insertion.The sensor was tested in-house, and the review of investigation analysis revealed a loss of chemical performance.The system correctly disabled the sensor when it detected the performance failure, and the system's self-test functions were working normally.The root cause of the performance failure was due to the sensor's hydrogel oxidation.As part of resolution, a return material authorization was issued for sensor replacement.No further resolution was necessary for this complaint.B4.Date of this report updated to 13 may 2024.B5.Describe event or problem updated.D9.Is this device available for evaluation? yes, 22 april 2024.G3.Date received by manufacturer updated by 10 may 2024.H3.Device evaluated by manufacturer? yes.H6.Type of investigation updated to 10.H6.Investigation findings updated to 3231.H6.Investigation conclusions updated to 4307.
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Event Description
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On (b)(6), 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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Search Alerts/Recalls
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