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 received a "replace sensor" error message with the adc device and was unable to obtain readings.As a result, customer experienced dizziness, tremor, loss of vision, a loss of consciousness, and was unable to self-treat.Customer had contact with a healthcare professional (hcp) who provided a glucose injection as treatment and obtained a blood glucose result of 398 mg/dl on an hcp meter.There was no report of death or permanent impairment associated with this event.
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