A complaint was received via webform regarding the adc device detached after day 1 of wear.As a result, on (b)(6) 2022, the customer experienced dizziness and a fall and was provided 3 units of rapid insulin by a non-hcp based on a glucose test of 240 mg/dl obtained on an unknown device.The customer indicated being hospitalized for a fractured radius and ulna due to fall, however, no additional diabetes-related treatment was reported.No further treatment or 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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