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 record) for the libre reader were reviewed, and the dhrs showed the libre reader 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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A customer reported an issue with the adc device, with the reader display freezing.The customer subsequently became dizzy and lost consciousness.The customer reported they were taken to hospital for treatment, but did not know what was provided.There was no report of death or permanent injury associated with this event.
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