BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LIBRE 3 PLUS

    MDR report key: 23974741 · Received January 6, 2026

    Report

    Report Number
    MW5181803
    Event Type
    Malfunction
    Date Received
    January 6, 2026
    Date of Event
    December 29, 2025
    Report Date
    December 30, 2025
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    QBJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PERSONAL CARE ASSISTANT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT'S PERSONAL ASSISTANT CALLED TO REPORT CONTINUOUS GLUCOSE MONITORING DEVICE'S SENSOR ONLY LASTING 2 DAYS. THIS HAPPENED PREVIOUSLY WITH ANOTHER SENSOR ABOUT 3 MONTHS EARLIER BUT THE ASSISTANT THOUGHT IT WAS ONE TIME THING. SHE CONTINUED ON & UTILIZED THE OTHER SENSOR IN THE BOX. THIS TIME AROUND THE ISSUE WAS CONFIRMED BY THE RECALL LETTER THEY (PATIENT AND PERSONAL ASSISTANT) RECEIVED FROM ABBOTT DIABETES CARE INC. THE SENSOR WAS WORKING FINE FOR 1 DAY AND ON THE 2ND THE DEVICE ISSUED A MESSAGE STATING THAT THE SENSOR NEEDED TO BE REPLACED. PATIENT HASN'T EXPERIENCED ANY ADVERSE SIGNS OR SYMPTOMS BECAUSE OF THE SENSOR BEING FAULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46274 FREESTYLE LIBRE 3 PLUS INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ ABBOTT DIABETES CARE INC. 78768

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other