BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LIBRE 3 SENSORS

    MDR report key: 23770945 · Received December 10, 2025

    Report

    Report Number
    MW5180280
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Date of Event
    November 1, 2025
    Report Date
    December 5, 2025
    Manufacturer
    ABBOTT DIABETES CARED, INC.
    Product Code
    QBJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SERIES OF FAULTY LIBRE FREESTYLE 3 SENSORS. CURRENTLY NOT INCLUDED IN RECALL. SN(B)(6). PT CODE: 4582. DEVICE CODE: 3023. REF REPORTS: MW5180279, MW5180281.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2554709 FREESTYLE LIBRE 3 SENSORS INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ ABBOTT DIABETES CARED, INC. T60003512

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male