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 a delivery delay with a replacement adc device.The replacement device was issued as customer had reported the adc device would not power on with either button press or test strip insertion.Due to delivery delay, customer reported an adverse event in which the customer lost consciousness.However, the customer reported being able to self-treat with rapid insulin (dose unknown).There was no report of death or permanent injury associated with this event.
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