BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 5765318 · Received July 1, 2016

    Report

    Report Number
    1052693-2016-01179
    Event Type
    Malfunction
    Date Received
    July 1, 2016
    Date of Event
    June 9, 2016
    Report Date
    July 1, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER'S TEST STRIP HAD POOR FILL.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH FASTING METER TO METER COMPARISON BLOOD GLUCOSE TEST RESULTS FROM TRUERESULT METER OF 78 MG/DL AND FROM ALTERNATE METER OF 126 MG/DL ON (B)(6) 2016 AT 07:30AM. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 101 TO 130MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/24/2018 AND OPEN VIAL DATE IS (B)(6) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: A 133MG/DL (B)(6) 2016 07:30 AM, FASTING: YES. A 131MG/DL (B)(6) 2016 07:30 AM, FASTING: YES. A 119MG/DL (B)(6) 2016 07:30 AM, FASTING: YES. A 126MG/DL (B)(6) 2016 07:30 AM, FASTING: YES. A 106MG/DL (B)(6) 2016 07:30 AM, FASTING: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420901 TRUERESULT BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUERESULT PT2698

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY