Model Number 81864 |
Device Problems
Device Alarm System (1012); Imprecision (1307)
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Patient Problem
Hypoglycemia (1912)
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Event Date 07/28/2019 |
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 and reported the continuous glucose monitoring system had an inaccurate reading and as a result did not alert her.The user did not require medical attention.
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Manufacturer Narrative
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Based on the investigation there was no malfunction observed with the eversense continuous glucose monitoring (cgm) system.Device code was updated to 1307.Results code was updated to 213.Conclusions code was updated to 67.
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Search Alerts/Recalls
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