The reported product is not expected to be returned as reporter indicated the device was discarded.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Clinical data was reviewed and confirmed that freestyle libre sensor continue to be safe, effective, and perform as intended in the field.A tripped trend review was completed for the reported complaint and fs libre sensors, and there were no adverse trends that indicate any potential product related issues.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.The device mfg date is unknown.The date entered in is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
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An adhesive issue was reported with the freestyle libre 2 sensor.The sensor prematurely detached after less than 1 day of wear and the customer was unable to obtain readings and monitor glucose levels.As a result, customer experienced hypoglycemia, cramping, and experienced a seizure and loss of consciousness.Customer received unspecified treatment by third-party and had contact with an hcp who provided intravenous glucose as treatment.There was no report of death or permanent injury associated with this event.
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