Model Number 102208-500 |
Device Problem
Device Alarm System (1012)
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Patient Problem
Hyperglycemia (1905)
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Event Date 08/23/2019 |
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)(4) 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.The user did not require medical attention.
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Manufacturer Narrative
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Based on the data available on the system,it would appear that the system functioned as designed.All hyper alerts were triggered and displayed in the system.The transmitter was not available to further investigate on the issue.H6 code updated to 3221.H6 code updated to 67.
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Search Alerts/Recalls
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