Model Number 102208-500 |
Device Problems
Imprecision (1307); Inaccurate Information (4051)
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Patient Problem
Hypoglycemia (1912)
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Event Date 06/18/2019 |
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 hypoglycemia event and was assisted by the emt that was called by a bystander.The user did not require hospitalization.
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Manufacturer Narrative
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Based on the investigation results there was no malfunction observed with the eversense continuous glucose monitoring (cgm) system.
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Search Alerts/Recalls
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