BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LIBRE 3

    MDR report key: 23679253 · Received December 1, 2025

    Report

    Report Number
    MW5179550
    Event Type
    Malfunction
    Date Received
    December 1, 2025
    Date of Event
    November 24, 2025
    Report Date
    November 25, 2025
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    QBJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT CALLED IN TO REPORT 2 SENSOR FAILURES WITH THE ABBOTT'S FREESTYLE LIBRE 3. NO ADVERSE EVENT REPORTED DUE TO FAILURES. PT CODE: 4582. DEVICE CODES: 1559, 3023. REF REPORT: MW5179549.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 12/3/2025 FOR REPORT MW5179550 TO UPDATE THE PROCODE TO QBJ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2093122 FREESTYLE LIBRE 3 INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ ABBOTT DIABETES CARE INC. T60003544

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male