BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBRE 3+ CGM

    MDR report key: 24033069 · Received January 12, 2026

    Report

    Report Number
    MW5182000
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    January 4, 2026
    Report Date
    January 4, 2026
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    QBJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    LIBRE 3+ SENSORS CONSISTENTLY FAIL BEFORE THE 15 DAYS IS UP.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 01/14/2026 FOR MW5182000 TO UPDATE PROCODE TO QBJ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94413 LIBRE 3+ CGM INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 3

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male INSULIN.| BABY ASPIRIN.| CREON.| LISINOPRIL.| MELOXICAM.| VITAMIN D.