BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE TRACK GLUCOMETER

    MDR report key: 7818536 · Received August 24, 2018

    Report

    Report Number
    MW5079391
    Event Type
    Injury
    Date Received
    August 24, 2018
    Date of Event
    August 22, 2018
    Report Date
    August 23, 2018
    Manufacturer
    NIPRO DIAGNOSTICS, INC. / TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I AM (B)(6), I FAILED MY 1 HR GLUCOSE CHALLENGE, AND PICKED UP A TRUE TRACK GLUCOMETER AT THE LOCAL PHARMACY IN ORDER TO TEST MY GLUCOSE. ALL OF THE READINGS WERE HIGH ENOUGH THAT I DECLINED THE 3 HOUR TEST AND WAS REFERRED TO START INSULIN THERAPY ON THE BASIS OF SIGNIFICANTLY ELEVATED FASTING GLUCOSE. WHEN I SHOWED UP FOR DIABETES EDUCATION YESTERDAY AND TO LEARN HOW TO USE AN INSULIN PEN. I NOTICED THAT THE NEW METER THEY GAVE ME WAS CONSISTENTLY LOWER THAN THE ONE I HAD PURCHASED OVER THE COUNTER NOT TWO WEEKS EARLIER. I ALERTED MY MFM, WHO IS HAVING ME CONTINUE TO TEST ON THE NEW MONITOR WHILE NOT INITIATING INSULIN THERAPY. MY FASTING LEVEL THIS MORNING IS 90 ON THE NEW MONITOR. I ALMOST STARTED INSULIN THERAPY, DURING PREGNANCY, ON THE BASIS OF TESTING ON A BRAND NEW MONITOR WHICH APPEARS TO BE IN FACT FAULTY. THIS COULD HAVE CAUSED SERIOUS HARM TO ME, AND TO MY (B)(6). IT'S NOT EVEN CLEAR TO ME AT THIS POINT THAT THE READINGS I OBTAINED WERE VALID ENOUGH TO DEMONSTRATE THAT I HAVE GESTATIONAL DIABETES, MUCH LESS GDM REQUIRING INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656240 TRUE TRACK GLUCOMETER SYSTEM TEST, BLOOD GLUCOSE NBW NIPRO DIAGNOSTICS, INC. / TRIVIDIA HEALTH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Life Threatening| O