At this time, product has not yet been returned.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.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.
|
A customer reported a "scan again in 10 minutes" message with the freestyle libre sensor.The customer was unable to obtain scan readings, and reported subsequently experiencing headache, excessive thirst, excessive urination, fatigue, and blurred vision.The customer went to a hospital where he was treated with bolus insulin.A healthcare meter result of 4.79 mmol/l was also reported, taken at unspecified time.There was no report of death or permanent injury associated with this event.
|