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 review) for the libre sensor and libre sensor kit 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.
|
A customer reported that a sensor error message was received on the adc device.As a result, the customer was unable to obtain sensor scans and experienced symptoms of shaking, cold, unable to move properly, and a loss of consciousness.The customer was treated with glucagon injection by a third party for treatment.No further information was reported.There was no report of death or permanent injury associated with this event.
|