BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4122531 · Received September 22, 2014

    Report

    Report Number
    1052693-2014-00351
    Event Type
    Malfunction
    Date Received
    September 22, 2014
    Date of Event
    August 25, 2014
    Report Date
    December 24, 2015
    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). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECT FOUND ON THE METER AND RETURNED TEST STRIPS OBSERVED BLACK CHEMISTRY. MOST LIKELY ROOT CAUSE IS BLACK CHEMISTRY DUE TO IMPROPER 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 "LO". LAST 5 TESTS IN MEMORY ALL READ "LO". CUSTOMER NORMALLY READS BETWEEN 130-170MG/DL. NO ADVERSE EVENT REPORT.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "LO". LAST 5 TESTS IN MEMORY ALL READ "LO". CUSTOMER NORMALLY READS BETWEEN 130 - 170MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587615 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PN1067

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR