The reported product is not expected to be returned as the device was reportedly discarded.A valid serial number has not been provided.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 sensors continue to be safe, effective, and perform as intended in the field.Stability data for freestyle libre sensors was reviewed and showed no anomalies or non-conformances that could have led to the complaint.A tripped trend review was conducted for the reported complaint and freestyle libre sensors, no trends were identified that would indicate any 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 section h4 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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A low readings issue was reported with the adc device.The customer reported 'lo' (< 40 mg/dl) sensor readings, and experienced shaking, tremors, and had loss of consciousness.The customer was unable to self-treat and had contact with a healthcare professional (hcp) who obtained a blood glucose result of 326 mg/dl on the healthcare meter.The customer was treated with unspecified fluids for diagnosis of diabetic ketoacidosis (dka).There was no report of death or permanent injury associated with this event.
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