BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 3 PLUS

    MDR report key: 23802907 · Received December 15, 2025

    Report

    Report Number
    MW5180481
    Event Type
    Injury
    Date Received
    December 15, 2025
    Date of Event
    December 5, 2025
    Report Date
    December 8, 2025
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    QBJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    FREESTYLE LIBRE 3 PLUS DIED IN DAY 4 AFTER PUTTING ON. SAID SENSOR MALFUNCTION; 4TH SENSOR IN A ROW THAT EITHER SHOWED LOW BLOOD SUGAR OR DIED BEFORE 14 DAYS. PT CODE: 1905. DEVICE CODES: 2460, 4019. REF REPORTS: MW5180479, MW5180480, MW5180482.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 12/17/2025 FOR REPORT MW5180481 TO UPDATE THE PROCODE TO QBJ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283056 FREESTYLE LIBRE 3 PLUS INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ ABBOTT DIABETES CARE INC. LIBRE 3 PLUS T60003622

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention EZETIMBE.| FINIFIBRATE.| LOSARTIN.| METFORMAIN.| MULTI VITAMINS.| RUVASTATION.| RYBELLUS.