BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 5694952 · Received June 2, 2016

    Report

    Report Number
    1052693-2016-01047
    Event Type
    Malfunction
    Date Received
    June 2, 2016
    Date of Event
    May 10, 2016
    Report Date
    June 2, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. RETURNED TEST STRIPS EVALUATED WITH DEFECT FOUND. THE MOST LIKELY ROOT CAUSE OF PQQ-PD LOT PT2717 READ LOW IN METER GLUCOSE READINGS IS DUE TO RETURNED STRIPS WERE LEFT OUTSIDE OF RETURNED VIAL FOR PROLONGED OF TIME OR WERE EXPOSED TO A HUMID ENVIRONMENT.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. CUSTOMER STATED HIS NORMAL BLOOD SUGAR RANGE OF READING IS BETWEEN 80-120 MG/DL FASTING AND 120-140 MG/DL WITHIN TWO HOURS AFTER EATING. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL INTERVENTION IS NOT REPORTED AT THIS TIME. DURING THE CALL ON (B)(6) 2016, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 132 MG/DL AND 128 MG/DL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/28/2019 AND OPEN VIAL DATE IS (B)(6) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350439 TRUERESULT BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUERESULT PT2717

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY