FREESTYLE LIBRE 3

Description of Event or Problem

A WEBFORM COMPLAINT WAS RECEIVED IN WHICH IT WAS REPORTED THE ADC DEVICE PREMATURELY DETACHED AND CUSTOMER WAS UNABLE TO OBTAIN READINGS. AS A RESULT, CUSTOMER RECEIVED TREATMENT OF JUICE, SUGAR, OR FOOD PROVIDED BY A NON-HEALTHCARE PROFESSIONAL. NO FURTHER DETAILS WERE PROVIDED AND ATTEMPTS TO GATHER ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

Additional Manufacturer Narrative

THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. AT THIS TIME PRODUCT HAS NOT YET BEEN RETURNED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. THE DEVICE HISTORY RECORDS (DHRS) FOR THE FREESTYLE LIBRE SENSOR KIT WERE REVIEWED AND THE DHRS SHOWED THE FREESTYLE LIBRE SENSOR KIT PASSED ALL TESTS PRIOR TO RELEASE. IF THE PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED AND A FOLLOW-UP REPORT SUBMITTED. THE DATE OF EVENT IS UNKNOWN. THE DATE ENTERED IN SECTION B3 IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.