The reported product is not expected to be returned as the device was reportedly discarded.An extended investigation has been performed for the reported complaint, and it has been determined that there was no indication that the product did not meet specification.The dhrs (device history record) for the libre sensor and libre sensor kit were reviewed, and the dhrs showed the libre sensor and libre sensor kit passed all tests prior to release.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 healthcare professional reported a sensor error message with the freestyle libre 2 sensor.The customer was unable to obtain scan readings, and experienced dizziness, shaking, and chills.A glucose result of 30 mg/dl was obtained with a capillary meter and the customer treated with glucose by the healthcare professional.There was no report of death or permanent injury associated with this event.
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