BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENSTRIP 50

    MDR report key: 6345453 · Received February 16, 2017

    Report

    Report Number
    MW5067959
    Event Type
    Malfunction
    Date Received
    February 16, 2017
    Date of Event
    February 15, 2017
    Report Date
    February 16, 2017
    Manufacturer
    PHARMATECH SOLUTIONS
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM TYPE 2 DIABETIC. YESTERDAY I WAS GIVEN GENSTRIP50 TESTING STRIPS LOT AA135 EXPERIENCE (B)(6) 2018 STRIPS FOR MY ONETOUCH ULTRA 2 METER. LAST EVENING I FELT THAT MY BLOOD GLUCOSE WAS VERY LOW. TESTING WITH THE GEN STRIP GAVE A READING OF 96. I FELT THIS WAS TOO HIGH AND RETESTED WITH LIFE SCAN BRAND OF STRIPS A MORE ACCURATE READING OF 73. THE GENSTRIP 50 STRIPS WERE 31.5 PERCENT HIGHER. THIS COULD HAVE LIFE THREATENING IMPLICATIONS WITH SUCH A DRASTIC VARIANCE IN ACCURACY. I DID THREE MORE COMPARISONS THROUGHOUT THE DAY IN THE TESTING GENSTRIPSERVICES WERE HIGH BY AVERAGE OF 14 PERCENT COMPARED TO THE ONETOUCH BRAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120485 GENSTRIP 50 SYSTEM, TEST, BLOD GLUCOSE NBW PHARMATECH SOLUTIONS GENSTRIP 50

    Patients

    Seq Age Sex Outcome Treatment
    1 Other