Model Number 102208-500 |
Device Problem
Device Alarm System (1012)
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Patient Problem
Hyperglycemia (1905)
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Event Date 11/06/2019 |
Event Type
Injury
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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 november 06th, 2019 senseonics was made aware of an adverse event where the user experienced a hyperglycemia event and reported the continuous glucose monitoring system did not alert her.
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Manufacturer Narrative
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Then complaint cannot be confirmed,since the system triggered low and high glucose alerts and there was no material returned for investigation.
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Search Alerts/Recalls
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