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 and stability were reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.Stability data for libre sensors was reviewed and showed no anomalies or non-conformances that could have lead to the complaint.A tripped trend review was conducted for the reported complaint and fs libre sensors, no trends were identified that would indicate any product related issues.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.The device mfg date is unknown.The date entered 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 use of the adc freestyle libre 2 sensor.A customer reported receiving unspecified low sensor scans when compared to unspecified results from a competitor¿s brand meter.The customer experienced weakness and was unable to self-treat.The paramedics were called and upon their arrival, blood glucose readings of 2.9 mmol/l and then 8.0 mmol/l were obtained.The customer further reported receiving treatment from both hcp and non-hcp however, no treatment details were provided and no further information was provided.There was no report of death or permanent impairment associated with this event.
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