A caregiver reported that the freestyle libre 2 reader is experiencing unspecified failure, and additionally no longer charges.The caregiver was therefore unable to obtain glucose results or alarms from reader, and the customer became hyperglycemic, requiring treatment of insulin from the caregiver.There was no report of death or permanent injury associated with this event.
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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 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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