BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 6202445 · Received December 23, 2016

    Report

    Report Number
    1000113657-2016-02088
    Event Type
    Malfunction
    Date Received
    December 23, 2016
    Date of Event
    December 1, 2016
    Report Date
    December 23, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD AN INACCURATE REFERENCE.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM ALL OF THE RESULTS OBTAINED. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 TO 100MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/24/2019 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: 149MG/DL (B)(6) 2016 07:00 AM FASTING: YES; 201MG/DL (B)(6) 2016 07:00 AM FASTING: YES; 308MG/DL (B)(6) 2016 01:00 PM FASTING: YES; 426MG/DL (B)(6) 2016 07:00 AM FASTING: YES; 418MG/DL (B)(6) 2016 01:00 PM FASTING: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852085 TRUERESULT BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUERESULT PT2746

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY