A caller reported an error message with the adc device, and was therefore unable to obtain sensor readings.The customer became hot and dizzy, requiring treatment of juice and bread by a third-party.There was no report of death or permanent injury associated with this event.
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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 and libre sensor kit were reviewed, and the dhrs showed the libre sensor and 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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