BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GLOUSE MONITOR

    MDR report key: 23759880 · Received December 9, 2025

    Report

    Report Number
    MW5180207
    Event Type
    Malfunction
    Date Received
    December 9, 2025
    Report Date
    December 2, 2025
    Manufacturer
    ABBOTT DIABETES CARE, INC.
    Product Code
    QBJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    HAD EXPERIENCE WITH FREESTYLE LIBRE 3 AND FREESTYLE LIBRE 3 PLUS FROM EARLY (B)(6) 2025 THROUGH MID-(B)(6) 2025 FOR MY BLOOD SUGAR MONITORING PER MY DOCTOR'S INSTRUCTION AFTER MY OPEN-HEART SURGERY. THE ALARM FUNCTIONS OF BOTH PRODUCTS FAILED FREQUENTLY AND SHOWED FALSE READINGS WHICH CAUSED HORRIBLE REACTIONS, ESPECIALLY IT HAPPENED MANY TIMES DURING MID-NIGHT AND AFFLICTED SLEEP TOTALLY. I FINALLY DECIDED TO STOP USING THESE FREESTYLE LIBRE PRODUCTS AND SWITCH BACK TO FINGER PICK MONITORING SYSTEM. PT CODE: 2517. DEVICE CODES: 1012, 1535. REF REPORT: MW5180206.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2885246 BLOOD GLOUSE MONITOR INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ ABBOTT DIABETES CARE, INC. LIBRE 3 PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other ASPIRIN 81MG.| JARDIANCE.| LISINOPRIL.| METFORMIN ER.| METOPROLOL TARTRATE.| ROSUVASTATIN.