BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LIBRE 2 SENSOR

    MDR report key: 19359149 · Received May 20, 2024

    Report

    Report Number
    MW5155149
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Date of Event
    May 16, 2024
    Report Date
    May 16, 2024
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    QBJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    APPLIED A NEW ABBOTT FREESTYLE LIBRE 2 GLUCOSE SENSOR TO MY ARM. ABOUT FOUR HOURS IT FELL OFF. UPON INSPECTION, I NOTICED THAT THE NEEDLE AND SOME OF THE WHITE PAPER ON THE BASE SHOWED SIGNS OF RUST. THIS WAS FROM LOT NUMBER KTP008460, SERIAL NUMBER (B)(6), USE BY 2034-10-31.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1609339 FREESTYLE LIBRE 2 SENSOR INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ ABBOTT DIABETES CARE INC. KTP008460

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female MULTIVITAMIN.