The product has been requested back for an investigation.At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The device history records (dhrs) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and 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 "scan again in 10 minutes" error message was reported with the adc device and the customer was unable to obtain readings.As a result, the customer experienced loss of consciousness however, there was no third-party intervention reported as no further information was reported.There was no report of death or permanent impairment associated with this event.
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