At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint and 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.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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Customer reported attempting to apply an adc device and being unsuccessful due to the inserter not firing, and as a result of being unable to monitor glucose levels, experiencing sweating and tremors.Customer had contact with healthcare professional who administered sugar orally.There was no report of death or permanent impairment associated with this event.
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