BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LIBRE 3

    MDR report key: 23831269 · Received December 17, 2025

    Report

    Report Number
    MW5180745
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    December 10, 2025
    Report Date
    December 15, 2025
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    QBJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE REPORTER CONTACTED US REGARDING THE FREESTYLE LIBRE 3. THEY RECEIVED A RECALL LETTER, WHICH INCLUDED ABOUT TEN OF THE LOT NUMBERS THEY HAD. THEY ALSO REPORTED THAT SOME OF THEIR SENSORS WERE NOT FUNCTIONING PROPERLY, SHOWING LOW READINGS AND NOT LASTING THE FULL 15-DAY CYCLE. PATIENT CODE: 4582. DEVICE CODES: 1420, 2460, 1506. REFERENCE REPORTS# MW5180736, MW5180737, MW5180738, MW5180739, MW5180740, MW5180741, MW5180742, MW5180743, MW5180744.

    Description of Event or Problem · 0

    ADD'L INFO RECEIVED FOR REPORT MW5180745 ON 01/05/2026 TO UPDATE THE PROCODE TO QBJ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2040600 FREESTYLE LIBRE 3 INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ ABBOTT DIABETES CARE INC. T60003498

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male