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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A delivery delay with a replacement adc device was reported.The replacement device was issued due to a sensor prematurely detached and the customer was unable to obtain readings.Due to delivery delay, customer was unable to test and experienced dizziness, "hemorrhage from the finger", requiring treatment of sachet of sugar with water via non-healthcare professional.There was no report of death or permanent impairment associated with this event.
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