BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4251140 · Received November 5, 2014

    Report

    Report Number
    1052693-2014-00493
    Event Type
    Malfunction
    Date Received
    November 5, 2014
    Date of Event
    October 8, 2014
    Report Date
    January 7, 2016
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION USER'S TEST STRIP HAD POOR STORAGE.

    Additional Manufacturer Narrative · 1

    PRODUCT NOT YET RETURNED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "HI". CUSTOMER NORMALLY READS AROUND 300MG/DL. LAST 5 BLOOD RESULTS IN MEMORY: HI, HI, 335MG/DL, 425MG/DL, 600MG/DL. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "HI". CUSTOMER NORMALLY READS AROUND 300MG/DL. LAST 5 BLOOD RESULTS IN MEMORY: HI, HI, 335MG/DL, 425MG/DL, 600MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710012 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR1817

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR