BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LIBRE 2 SENSOR

    MDR report key: 15276296 · Received August 22, 2022

    Report

    Report Number
    MW5111651
    Event Type
    Malfunction
    Date Received
    August 22, 2022
    Date of Event
    August 18, 2022
    Report Date
    August 18, 2022
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    QLG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    "I HAVE THE FREESTYLE LIBRE 2 SENSOR AN 3MH060UJ9MD, LOT KTP003874, 23-01-31. WHAT YOU INFO N BOX READER FOR IT KEEPS COMING UP WITH SENSOR ERROR ON READER I USE (B)(4) TO GET THE SUPPLIES FOR THESE CALLED ABBOTT DIABETS CARE INC BUT KEEP GETTING THESE EVER ORDER I PLACE THROW (B)(4) AND ALL WAY NEED THEM REPLACED THIS NEEDS TO BE FELT WITH PEOPLE CAN'T CHECK THEIR BLOOD SUGAR AT ALL UNTIL WAIT 15 MIN TO TRY WHEN OR IT FAIL AGEN." FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2446356 FREESTYLE LIBRE 2 SENSOR INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE QLG ABBOTT DIABETES CARE INC. KTP003874

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Other