The product has been requested back for an investigation.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 device history records (dhrs) for the fs libre sensor and fs libre sensor kit were reviewed, and the dhrs showed the fs libre sensor and 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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An error message was reported with the abbott diabetes care (adc) device.Customer received a "replace sensor" message.And was unable to obtain readings.As a result, customer experienced a loss of consciousness, "loss of knowledge".And was unable to self-treat, requiring third-party treatment of "food" by a non-healthcare professional.There was no report of death or permanent impairment associated with this event.
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