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Model Number 21-7231 |
Device Problem
Device Operational Issue (2914)
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Patient Problem
Hyperglycemia (1905)
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Event Type
malfunction
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Manufacturer Narrative
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Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
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Event Description
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According to reporter, site did not adhere upon application.Blood glucose level increased as a result of this event.No adverse health outcome reported.
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Search Alerts/Recalls
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