BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 5498327 · Received March 14, 2016

    Report

    Report Number
    1052693-2016-00501
    Event Type
    Malfunction
    Date Received
    March 14, 2016
    Date of Event
    February 19, 2016
    Report Date
    March 14, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECT FOUND ON RETURNED METER. 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'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 120 MG/DL. THE CUSTOMER REPORTED FEELING WEAK. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE CUSTOMER IS CURRENTLY TAKING MEDICATION TO MANAGE DIABETES. ON (B)(6) 2016, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED A TEST RESULT OF 185 MG/DL. THE PRODUCT IS STORAGE IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/14/2018 AND OPEN VIAL DATE IS THE MONTH OF (B)(6) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: 1:188MG/DL (B)(6) 2016 04:07PM FASTING:YES, 2:179MG/DL (B)(6) 2016 05:59PM FASTING:YES, 3:174MG/DL (B)(6) 2016 05:44PM FASTING:YES, 4:153MG/DL (B)(6) 2016 05:33PM FASTING:YES, 5:164MG/DL (B)(6) 2016 05:50PM FASTING:YES, ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152892 TRUERESULT BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUERESULT PS2535

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY