Model Number 71953-01 |
Device Problems
Failure to Power Up (1476); 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 01/12/2023 |
Event Type
Injury
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Event Description
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A battery/no power issue was reported with the adc device reader.Customer was unable to test due to the reader not powering on with button press or test strip insertion and as a result, the customer experienced symptoms of "general bad feeling" and received fluids intravenously as treatment from a healthcare professional.No further information was provided.There was no report of death or permanent impairment associated with this event.
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Manufacturer Narrative
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The product has been requested back for an investigation.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.A tripped trend review was conducted for the reported complaint and freestyle libre reader and no trends were identified that would indicate any product related issues.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The device mfg date is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
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Search Alerts/Recalls
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