BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4180711 · Received October 15, 2014

    Report

    Report Number
    1052693-2014-00405
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 17, 2014
    Report Date
    January 4, 2016
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND ON THE METER.DEFECT STRIP. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION:STRIPS IMPROPER STORAGE.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND ON THE METER. DEFECT STRIP. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION:STRIPS IMPROPER STORAGE. PRODUCT CODES UPDATED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "LO." LAST 4 TESTS IN MEMORY: 94 MG/DL, "LO," "LO," AND "LO." NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "LO". LAST 4 TESTS IN MEMORY: 94MG/DL, "LO", "LO", AND "LO" NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "LO". LAST 4 TESTS IN MEMORY: 94MG/DL, "LO", "LO", AND "LO." NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653657 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PP1733

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR