BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 5659914 · Received May 17, 2016

    Report

    Report Number
    1052693-2016-00949
    Event Type
    Malfunction
    Date Received
    May 17, 2016
    Date of Event
    April 20, 2016
    Report Date
    May 17, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) (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 PS2508 READ LOW IN METER GLUCOSE READINGS IS DUE TO THE RETURNED STRIP WERE LEFT OUTSIDE OF RETURNED VIAL FOR PROLONGED OF TIME WHICH CAUSED LOW BLOOD READINGS.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF LOW RESULTS. CUSTOMER STATES THAT SHE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULT IS 100-130MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 9/23/2018. CUSTOMER CONFIRMS THE STRIPS HAVE BEEN PROPERLY STORED AND WERE FIRST OPENED (B)(6) 2016. THE METER DID REGISTER WITHIN CONTROL TEST AND LAST TEST OF 116MG/DL WAS WITH THE PATIENTS RANGE. REVIEWED METER MEMORY (B)(6). MEMORY CONCERNS:76 AND 74 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314414 TRUERESULT BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUERESULT PS2508

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY