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.
|
An error message was reported with the adc device.Customer received a "scan again in 10 minutes" message and was unable to obtain readings.As a result, customer experienced a loss of strength, weakness, dizziness, and aggressiveness and was unable to self-treat, requiring third-party administration of oral glucose for treatment.There was no report of death or permanent impairment associated with this event.
|