Abbott diabetes care received a medwatch report which reported the following information: a pharmacist reported on behalf of the customer issues when applying two freestyle libre 2 sensors.It was reported that for one sensor, the application needle came out of the back of the sensor, and with the other sensor, the filament bent upon insertion.There was no report of adverse event or third-party intervention required due to the reported issue.Based on the information provided, there was no report of serious injury associated with this event.
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This is an initial final report. this issue does not meet reportability criteria; however, it is being reported to the fda as the complaint was received via user report.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The consumer reported issues with 2 freestyle libre sensors, all with unknown serial numbers.This report covers both sensors.The device manufacturing 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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