BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 7940001 · Received October 5, 2018

    Report

    Report Number
    1000113657-2018-01006
    Event Type
    Malfunction
    Date Received
    October 5, 2018
    Date of Event
    September 12, 2018
    Report Date
    October 5, 2018
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT NUMBER: MW5079391. NOTIFICATION RECEIVED THI: (B)(6) 2018. CUSTOMER PREVIOUSLY CONTACTED MANUFACTURER (REFERENCE RAN (B)(4) ) WITH A COMPLAINT WITH PRODUCT TRUE TRACK METER SN (B)(4) AND TEST STRIPS LOT# RV5183. PRODUCT RETURNED ON THAT RAN AND WAS EVALUATED. RETURNED METER EVALUATED WITH NO DEFECT FOUND. TEST STRIPS NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-55-USER HAD AN INACCURATE REFERENCE: COMPETITOR'S METER: THE END USER IS COMPARING RESULTS OBTAINED FROM TRIVIDIA'S BGM SYSTEM TO THE RESULTS FROM A COMPETITOR'S BGM SYSTEM NOTE: MANUFACTURER CONTACTED CUSTOMER (SEVERAL ATTEMPTS) IN A FOLLOW-UP CALL TO ENSURE THAT INITIAL CONCERN WAS RESOLVED - UNABLE TO ESTABLISH CONTACT WITH THE CUSTOMER AT THIS TIME.

    Description of Event or Problem · 1

    MEDWATCH SENT BY FDA. 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 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
    779215 TRUETRACK BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUETRACK N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR