BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4180724 · Received October 15, 2014

    Report

    Report Number
    1052693-2014-00409
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 17, 2014
    Report Date
    December 15, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT YET RETURNED FOR EVAL. (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 HAD AN INACCURATE REFERENCE OR USER REUSED TEST STRIP OR USER'S TEST STRIP HAD POOR FILL.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD RESULTS. CALLER NORMAL RANGE IS 100 MG/DL. LAST 4 RESULTS IN MEMORY WERE 63, 60, 65, 73, AND 65 MG/DL. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE LOWEST RESULT GIVEN (60) AND THE NORMAL RESULT (100) IS LOCATED IN ZONE C. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD RESULTS. CALLER NORMAL RANGE IS 100MG/DL. LAST 5 RESULTS IN MEMORY WERE 63MG/DL, 60MG/DL, 65MG/DL, 73MG/DL, AND 65MG/DL. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE LOWEST RESULT GIVEN (60) AND THE NORMAL RESULT (100) IS LOCATED IN ZONE C. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654684 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR1894

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR