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 that the date/time was incorrectly set on the adc device, and this issue reportedly led to a loss of consciousness.The customer reported having contact with her healthcare professional for unspecified diabetes and heart treatments, and additionally self-treated with various non-diabetes related medications.There was no report of death or permanent injury associated with this event.
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