BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT DIABETES CARE INC. FREE STYLE LIBRE 14 DAYS SENSOR ABBOTT

    MDR report key: 10975652 · Received December 8, 2020

    Report

    Report Number
    MW5098259
    Event Type
    Malfunction
    Date Received
    December 8, 2020
    Date of Event
    November 6, 2020
    Report Date
    December 4, 2020
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LIBRE FREE STYLE 14 DAYS SENSOR REPEATEDLY SHOWED LOW SUGAR NOT RESPONDING TO PO LARGE AMOUNT SUGAR INTAKE. FINALLY BOUGHT ACCUCHEK AND BLOOD SUGAR WAS IN 160-180 MG/DL. THE NEXT 2 SENSORS WERE ALSO SHOWING LOWER SUGAR BY 40 MG THAN WITH BLOOD SUGAR ACCUCHEKS. THE WHOLE BATCH IF 6 SENSORS ARE DEFECTIVE. NEW SENSOR FROM DIFFERENT BATCH IS CORRECTLY SHOWING SUGAR. THIS WAS NOTIFIED TO ABBOTT FREE STYLE 3 TIMES IN PAST AND AGAIN TODAY AFTER REALIZING THAT WHOLE BATCH IS DEFECTIVE. THERAPY DATE: (B)(6) 2020. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429099 ABBOTT DIABETES CARE INC. FREE STYLE LIBRE 14 DAYS SENSOR ABBOTT SENSOR, GLUCOSE, INVASIVE MDS ABBOTT DIABETES CARE INC. FREE STYLE LIBRE 14 DAYS
    1429100 FREE STYLE LIBRE 14 DAYS SENSOR ABBOTT SENSOR, GLUCOSE, INVASIVE MDS ABBOTT DIABETES CARE INC.
    1429101 FREE STYLE LIBRE 14 DAYS SENSOR ABBOTT SENSOR, GLUCOSE, INVASIVE MDS ABBOTT DIABETES CARE INC.
    1429102 FREE STYLE LIBRE 14 DAYS SENSOR ABBOTT SENSOR, GLUCOSE, INVASIVE MDS ABBOTT DIABETES CARE INC.
    1429103 FREE STYLE LIBRE 14 DAYS SENSOR ABBOTT SENSOR, GLUCOSE, INVASIVE MDS ABBOTT DIABETES CARE INC.
    1429104 FREE STYLE LIBRE 14 DAYS SENSOR ABBOTT SENSOR, GLUCOSE, INVASIVE MDS ABBOTT DIABETES CARE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other