BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 3

    MDR report key: 19281546 · Received May 9, 2024

    Report

    Report Number
    2954323-2024-16241
    Event Type
    Injury
    Date Received
    May 9, 2024
    Date of Event
    April 12, 2024
    Report Date
    May 9, 2024
    Manufacturer
    ABBOTT DIABETES CARE LTD
    Product Code
    QLJ
    PMA / PMN Number
    K212132
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MOST PROBABLE ROOT CAUSES ASSOCIATED WITH THIS FAILURE MODE ARE DISCONNECTED, FAULTY OR DAMAGED COMPONENTS, SOFTWARE/DATA CORRUPTION, OR MISUSE. HOWEVER, MITIGATIONS ARE IN PLACE TO REDUCE AND PREVENT SUCH ISSUES. ALL VITAL MANUFACTURING STEPS ARE VALIDATED, MONITORED, AND VERIFIED DURING MANUFACTURING TO ENSURE THE SYSTEM IS IN CONFORMANCE WITH THE VERIFIED DESIGN. ALL VITAL FUNCTIONS ARE MONITORED BY THE SYSTEM AND, WHEN NECESSARY, FUNCTION IS SUSPENDED TO SAFEGUARD AGAINST INACCURATE RESULTS. LABELING IS PROVIDED TO INSTRUCT THE USER ON THE INTENDED USE OF ALL VITAL PARTS OF THE SYSTEM TO MINIMIZE MISUSE. ALL COMPLAINTS AND COMPLAINT TRENDS ARE INVESTIGATED TO DETERMINE IF THERE IS A PRODUCT DEFECT/ DEFICIENCY. IF A PRODUCT DEFECT/ DEFICIENCY IS IDENTIFIED, A RISK EVALUATION IS COMPLETED AND COMPARED TO THE RISK MANAGEMENT REPORT, TO ENSURE THE RISK PROFILE HAS NOT CHANGED. ADDITIONALLY, AS A PART OF ABBOTT¿S POST-MARKET SURVEILLANCE PROCESS, ALL RISK EVALUATIONS WITH ASSOCIATED COMPLAINT DATA ARE REVIEWED ANNUALLY TO DETERMINE IF THE RISK PROFILES HAVE CHANGED AS COMPARED TO THE PRODUCT RISK MANAGEMENT REPORTS. THESE MONITORING PROCESSES ENSURE THAT ALL PRODUCT RISK PROFILES REMAIN ACCEPTABLE AND HAVE A POSITIVE BENEFIT/ RISK RATIO. THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. AT THIS TIME PRODUCT HAS NOT YET BEEN RETURNED. A VALID SERIAL OR LOT NUMBER WAS NOT 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 SENSORS CONTINUE TO BE SAFE, EFFECTIVE, AND PERFORM AS INTENDED IN THE FIELD. A TRIPPED TREND REVIEW WAS CONDUCTED FOR THE REPORTED COMPLAINT AND FREESTYLE 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 DATE OF EVENT IS UNKNOWN. THE DATE ENTERED IN SECTION B3 IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. THE DEVICE MFG 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.

    Description of Event or Problem · 0

    A "REPLACE SENSOR" ERROR MESSAGE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE AND THE CUSTOMER WAS UNABLE TO OBTAIN READINGS. AS A RESULT, THE CUSTOMER EXPERIENCED SWEATING AND A LOSS OF CONSCIOUSNESS. THE CUSTOMER WAS NOT ABLE TO TREAT THEMSELVES AND WERE TRANSPORTED TO A HOSPITAL BY AMBULANCE. AT THE HOSPITAL, A BLOOD GLUCOSE RESULT OF 54 MG/DL WAS OBTAINED, THE CUSTOMER WAS DIAGNOSED WITH HYPOGLYCEMIA, AND WAS HYDRATED FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489542 FREESTYLE LIBRE 3 CONTINUOUS GLUCOSE MONITORING SYSTEM QLJ ABBOTT DIABETES CARE LTD 72081-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention