The reported product is not expected to be returned as reporter indicated the device was discarded.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.Therefore, no further investigations planned.In the event that unanticipated product is received, a physical investigation will be performed per adc's established processes and procedures and a follow-up report will be submitted upon completion of investigation.All pertinent information available to abbott diabetes care has been submitted.
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A customer obtained the error message, "sensor ended,¿ while using the adc freestyle libre 2 sensor.As a result, on (b)(6) 2021, the customer experienced symptoms of hyperglycemia, had a fall, and lost consciousness.Hcp contact was made, an x-ray was performed, and provided the customer with multiple intravenous medications and insulin and blood glucose tests every 4 hours for the treatment of hyperglycemia.No further information was reported.There was no report of death or permanent injury associated with this event.
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