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 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 lower values when scanning the adc freestyle libre 2 sensor compared to an hcp meter.On (b)(6) 2020, the customer could not perform blood glucose test due to having the incorrect test strips, and subsequently fell and lost consciousness.The customer was then treated with 15 unknown medications by both non-hcp and hcp for a diagnosis of hypoglycemia.There was no report of death or permanent injury associated with this event.
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