Model Number 102208-610 |
Device Problem
Battery Problem (2885)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/24/2023 |
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 september 27, 2023, senseonics was made aware of an incident where a user complained about an overheating issue with transmitter when it was placed in charging cradle, which caused smoke coming from the cradle and melting of the cradle and transmitter pins.
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Manufacturer Narrative
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The user placed their transmitter to charge and noticed smoke coming from the cradle.The transmitter was warm to touch, and the user noticed that the plastic melted on the cradle and transmitter pins.The investigation found that the transmitter battery capacity was low and circuit board showed signs of liquid ingress all over it.As part of resolution, the rma was authorized to offer the user a transmitter replacement.B4.Date of this report updated to 10 january 2024.G3.Date received by manufacturer updated to 11 december 2023.H3.Device evaluated by manufacturer? yes.H6.Type of investigation updated to 10.H6.Investigation findings updated to 120.H6.Investigation conclusions updated to 4307.
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Search Alerts/Recalls
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