The reported product is not expected to be returned as the device was reportedly discarded.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 sensor kit were reviewed, and the dhrs showed the libre sensor kit passed all tests prior to release.In the event that unanticipated product is received, a physical investigation will be performed per adc's established processes and procedures and a follow-up report will be submitted upon completion of investigation.All pertinent information available to abbott diabetes care has been submitted.
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A customer reported the adc device detached prematurely after bumping against object.The customer became sweaty, nauseous, had palpitations, and was thirsty.The customer was taken to the emergency room where an unspecified blood glucose test result was obtained and the customer put on unspecified iv for diagnosis of hyperglycemia.There was no report of death or permanent injury associated with this event.
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