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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A complaint was received regarding the adc device inserter did not fire and the sensor did not apply.As a result, on (b)(6) 2022, the customer had a seizure and a loss of consciousness and was provided unspecified medical treatment by a healthcare professional.No further information was provided.There was no report of death or permanent injury associated with this event.
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