BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBRE 3 PLUS SENSOR

    MDR report key: 23867534 · Received December 22, 2025

    Report

    Report Number
    MW5180958
    Event Type
    Injury
    Date Received
    December 22, 2025
    Date of Event
    December 13, 2025
    Report Date
    December 13, 2025
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    QBJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    INSTALLED LIBRE PLUS CONTINUOUS GLUCOSE MONITOR SENSOR IN RIGHT ARM. THEIR DOCUMENTATION SAYS THE NEEDLE WILL NOT REMAIN IN THE ARM AFTER INSTALLATION. AFTER 10 TO 15 MINUTES, THE SENSOR CAME LOOSE. I FELT AROUND THE EDGE OF IT AND COULD FEEL THE NEEDLE IN MY ARM. WHEN I WITHDREW MY HAND, THERE WAS BLOOD COVERING MY FINGERS. AS I DABBLED A PAPER TOWEL AROUND THE SENSOR PERIMETER, THE PAPER TOWEL BECAME DRENCHED IN BLOOD AND THE SENSOR FELL OUT. I EXPERIENCED SEVERE BLEEDING WITH MULTIPLE PAPER TOWELS BEING DRENCHED IN BLOOD AND THE SLEEVE OF MY T-SHIRT DRENCHED AS WELL. I ESTIMATE ONE TO TWO BLOOD DRAW VIALS OF BLOOD VOLUME BLED FROM ME BEFORE BEING STOPPED. I CALLED THE COMPANY TO REPORT THE PROBLEM AND WAS TOLD BY THE CUSTOMER SUPPORT REPRESENTATIVE TO CALL MY DOCTOR. WHICH IS TOTALLY LUDICROUS AND UNACCEPTABLE WHEN THE PRODUCT FAILED TO WORK PROPERLY. THIS COMPANY IS NOT ACCEPTING RESPONSIBILITY FOR THEIR FAILURE. THEY'RE SAYING THIS IS THE DOCTOR'S FAULT IS A DISGRACE OF THEIR INTEGRITY TO PROTECT THE CONSUMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2517681 LIBRE 3 PLUS SENSOR INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ ABBOTT DIABETES CARE INC. 78769-01 T60003210

    Patients

    Seq Age Sex Outcome Treatment
    1 Male