A complaint was received regarding a sensor error message while using the adc device.As a result, on (b)(6) 2022, the customer experienced dizziness, weakness, and "couldn't get up" with a blood glucose test of 50 mg/dl obtained on an unknown device.Emergency services provided the customer with glucose for treatment.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 and libre sensor kits were reviewed 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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