A complaint was received regarding the detachment of the adc device on day 12 of wear.As a result, on (b)(6) 2022, the customer experienced delirium and "taking out of the ordinary" and had a seizure and lost consciousness requiring a cup of sugar by non-hcp and 2 glucose packets, cake with crackers, and cheese by paramedics for a diagnosis of hypoglycemia.No further information was provided.There was no report of death or permanent injury associated with this event.
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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 review) for the libre sensor kits were reviewed and the dhrs showed the 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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