BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LIBRE 3 SENSOR

    MDR report key: 21856252 · Received April 17, 2025

    Report

    Report Number
    MW5169272
    Event Type
    Malfunction
    Date Received
    April 17, 2025
    Date of Event
    April 14, 2025
    Report Date
    April 14, 2025
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    QBJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY FREESTYLE LIBRE 3 SENSOR IS REPORTING BLOOD GLUCOSE LEVELS 30 POINTS LOWER THAN THE TRUE BGL WHEN MEASURED BY A FINGER PRICK AND BGL READING OF A BLOOD DROPLET. THE SENSOR ID IS (B)(6), STATUS (B)(6). I WILL TRY TO OBTAIN A COMPLEMENTARY REPLACEMENT, EITHER THROUGH MY PHARMACIST OR FROM ABBOTT DIABETES CARE INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1733266 FREESTYLE LIBRE 3 SENSOR INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE QBJ ABBOTT DIABETES CARE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male