At this time product has not yet been returned and 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 sensor continue to be safe, effective, and perform as intended in the field.A tripped trend review was conducted for the reported complaint and libre sensors, no trends were identified that would indicate any product related issues.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The device manufacturing 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 healthcare professional (hcp) reported on behalf of a customer who indicated upon the adc device application, the sensor did not penetrate the skin, and upon "peeling it off, the white part inside the sensor was missing along with the filament¿.No symptoms were reported however, the customer had contact with an hcp who provided unspecified treatment.No further information was provided.There was no report of death or permanent impairment associated with this event.
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