BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBRE PLUS 3 SENSOR

    MDR report key: 23863403 · Received December 22, 2025

    Report

    Report Number
    MW5180894
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    December 2, 2025
    Report Date
    December 15, 2025
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    QBJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2025 LIBRE 3 PLUS SENSOR FAILED TO APPLY ON SKIN (SENSOR IS STILL ATTACHED ON DEVICE APPLICATOR) SRL # (B)(6), ON THE SAME DAY ANOTHER LIBRE SENSOR 3 PLUS FAILED UPON APPLICATION IT CAUSED BLEEDING THAT COVER 10% OF SENSOR NOT SURE IF WILL CAUSE TO GIVE FALSE READINGS SRL # (B)(6). PRIOR TO THIS DAY, I ALSO HAD MULTIPLE LOW GLUCOSE ALERTS (WHICH I DID NOT WRITE DOWN) MOSTLY BETWEEN 12:00 AM AND 5 AM ON AT LEAST 3 DIFFERENT DAYS WHICH I WANTED TO REPORT TO ABBOTT AFTER 2 FAILURES OF SENSOR ON THE SAME DAY!!! WHEN I CHECKED MY OTHER SENSORS AGAINST THE LIST ON THE FALSE READINGS THEY DIDN'T APPEARED BUT I WAS GETTING LOW FALSE ALARMS ANYWAYS, MAYBE MORE LOTS MAY BE AFFECTED THAN THOSE LISTED!! I AM NOT SURE IF PHARMACY THAT FILLED MY 90 DAY SUPPLY CAN'T GET THOSE SERIAL NUMBER?? I SWITCHED TO DEXCOM 7 AFTER SUFFERING FROM LACK OF GOOD SLEEP BECAUSE OF THE ALARMS GOING OFF. I WAS GOING TO TRY THEM AGAIN AFTER I CHECKED REMAINING SENSORS WERE "NOT AFFECTED" SINCE I PAID $$$$ FOR THE 3 MONTH SUPPLY. PT CODE: 1888. DEVICE CODES: 2547, 2460. REF REPORT: MW5180895.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2711099 LIBRE PLUS 3 SENSOR INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ ABBOTT DIABETES CARE INC. T60003359

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male 81MG ASPIRIN| ALBUTEROL IF WHIZZING| CLARITIN| LIPITOR 10 MG | MEN'S MULTI VITAMIN| NEXIUM RARE| OMEPRAZOLE 40 MG PRN | OZEMPIC 1MG | RHINOCORT