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.
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A customer reported an alarm issue with the freestyle libre 2 sensor.The customer reported the low glucose alarm failed to trigger when the customer became hypoglycemic, and the customer subsequently lost consciousness.A friend took the customer to a health center for treatment, but the customer could not recall what the treatment entailed.There was no report of death or permanent injury associated with this event.
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