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.Dhrs for the libre sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits 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 an unspecified higher scan value than how they felt while using the adc freestyle libre 2 sensor.As a result, on (b)(6) 2021, the customer had a loss of consciousness and was brought to the hospital where an unspecified blood glucose test was performed on the hcp meter was provided an injection of glucose for a diagnosis of hypoglycemia.No further information was reported.There was no report of death or permanent injury associated with this event.
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