BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREE STYLE LIBRE 3 SENSOR

    MDR report key: 19875062 · Received July 30, 2024

    Report

    Report Number
    MW5157821
    Event Type
    Malfunction
    Date Received
    July 30, 2024
    Date of Event
    March 1, 2024
    Report Date
    July 26, 2024
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    QBJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    FROM (B)(6) 2024, I HAVE HAD 4 DEFECTED SENSORS. I CONTACTED ABBOTT AND SENT ALL 4 BACK AT DIFFERENT TIMES AND TO DATE HAVE NOT RECEIVED 4 REPLACEMENTS. THEREFORE, I HAVE STOPPED USING THE SENSORS AND HAVE GONE BACK TO THE GLUCOSE MONITOR WITH FINGER STICKS. THIS IS DUE TO THE LACK OF COOPERATION FROM THE COMPANY. REFERENCE REPORT: MW5157822, MW5157823, MW5157824.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2075121 FREE STYLE LIBRE 3 SENSOR INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ ABBOTT DIABETES CARE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female