BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SENSOR

    MDR report key: 10162682 · Received June 16, 2020

    Report

    Report Number
    MW5095026
    Event Type
    Malfunction
    Date Received
    June 16, 2020
    Date of Event
    May 10, 2020
    Report Date
    June 12, 2020
    Manufacturer
    ABBOTT DIABETES CARE, INC
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    GLUCOSE MONITORING INCORRECT; USING THE FREE STYLE LIBRE GLUCOSE MONITORING SYSTEM. ON TWO SEPARATE OCCASIONS I FOUND THE DEVICE TO BE GIVING GROSSLY INACCURATE READINGS. I FOLLOWED THE DIRECTION OF USE. THIS OCCURRED USING TWO DIFFERENT SENSORS. MY LIBRE READ MY GLUCOSE AS 43 MG/DL. I KNEW THIS WAS INCORRECT. I USED A BLOOD TEST GLUCOMETER (RELION PRIME) WHICH SHOWED A GLUCOSE OF 440 MG/DL. I USED A ONE TOUCH ULTRA BLOOD TEST AND IT ALSO SHOWED A GLUCOSE LEVEL OF 435 MG/DL. I EXPERIENCED THIS WHILE USING TWO DIFFERENT FREE STYLE LIBRE SENSORS. I NO LONGER USE THE PRODUCT. IT IS TOO INACCURATE. THE READINGS ARE NOT VALID OR RELIABLE. FDA SAFETY REPORT ID# B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624475 FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SENSOR SENSOR, GLUCOSE, INVASIVE MDS ABBOTT DIABETES CARE, INC
    624476 FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SENSOR SENSOR, GLUCOSE, INVASIVE MDS ABBOTT DIABETES CARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other