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.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 exact date that the incident occurred is unknown.The date entered is based on the customer report of "(b)(6) 2019".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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A customer reported upon the removal of the adc freestyle libre 2 sensor in july 2019, the sensor filament got stuck in the skin and hcp contact was made.Customer further reported she is experiencing inflammation at the sensor site and that an operation would be required, but no further information was reported.There was no report of death or permanent injury associated with this event.
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