A complaint was received indicating missing the glucose alarm alert while using the adc device.As a result, on (b)(6) 2022, the customer experienced hypoglycemia symptoms and had a loss of consciousness.A lab blood glucose test of 40 mg/dl was obtained, and the customer was provided intravenous for a diagnosis of hypoglycemia.A post-treatment glucose test of 110 mg/dl was obtained and 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 reader; were reviewed and the dhrs showed the libre reader; 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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