Model Number 71992-01 |
Device Problem
Unable to Obtain Readings (1516)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/30/2022 |
Event Type
Injury
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Manufacturer Narrative
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At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the libre sensor and libre sensor kit were reviewed and the dhrs showed the libre sensor and libre sensor kit passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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An error message was reported with the adc device.Customer received a "replace sensor" message and was unable to obtain readings.As a result, customer experienced symptoms of "diabetic reaction".Customer was unable to self treat and paramedics arrived and administered unspecified iv fluid as treatment.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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