BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4190138 · Received September 18, 2014

    Report

    Report Number
    1052693-2014-00340
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 23, 2014
    Report Date
    December 17, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER'S TEST STRIP REUSED OR USER'S TEST STRIPS STORED IN HIGH ENVIRONMENTAL STORAGE CONDITION.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "LO." LAST FIVE TESTS IN MEMORY: "LO", 124 MG/DL, 135 MG/DL, 146 MG/DL. BACK TO BACK BLOOD RESULTS WERE 188 MG/DL AND 177 MG/DL. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "LO". LAST 5 TESTS IN MEMORY: "LO", 124MG/DL, 178MG/DL, 135MG/DL, 146MG/DL. BACK TO BACK BLOOD RESULTS WERE 188MG/DL AND 177MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578149 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PP1550

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR