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 the freestyle libre 2 reader would not turn on with either button press nor test strip insertion, due to damage to the charging port.The customer could not charge the reader and obtain glucose results, and the customer subsequently experienced sweating and dizziness, and required treatment of sugar-water by a friend.There was no report of death or permanent injury associated with this event.
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