An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.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.The reported product is not expected to be returned as reporter indicated the device was discarded.Therefore, no further investigations planned.In the event that unanticipated product is received, a physical investigation will be performed per adc's established processes and procedures and a follow-up report will be submitted upon completion of investigation.All pertinent information available to abbott diabetes care has been submitted.
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A bent sensor tip was reported with the adc device and customer was therefore unable to obtain readings.As a result, the customer experienced a loss of consciousness and upon regaining consciousness, she self-treated with carbohydrates.No third-party treatment was reported.There was no report of death or permanent injury associated with this event.
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