Model Number 102095-67A |
Device Problems
Device Alarm System (1012); Imprecision (1307)
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Patient Problem
Hypoglycemia (1912)
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Event Date 06/25/2019 |
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 (b)(6) 2019 senseonics was made aware of an adverse event where the user experienced a hypoglycemia event.The user reported that at night he turns the volume/sound off on his phone because he feels the alerts at night disturb his sleep.The user was able to self-treat and did not require any medical attention.
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Manufacturer Narrative
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The user received sensor replacement alert later on the same day.Based on the investigation there was a malfunction observed with the sensor and the algorithm accurately triggered the early sensor retirement alert for the sensor.
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Search Alerts/Recalls
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