BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4172422 · Received October 9, 2014

    Report

    Report Number
    1052693-2014-00402
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Date of Event
    September 13, 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
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    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.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT HIGH BLOOD RESULTS. CUSTOMER NORMAL RESULTS ARE 70-90 MG/DL BEFORE A MEAL OR MEDICATION. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE HIGHEST RESULT IN MEMORY (160) AND THE LOWEST RESULT (70) IS LOCATED IN ZONE B/C. LAST 6 RESULTS IN MEMORY ARE 152 MG/DL, 149 MG/DL, 160 MG/DL, 138 MG/DL, 110 MG/DL AND 161 MG/DL. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT HIGH BLOOD RESULTS. CUSTOMER NORMAL RESULTS ARE 70-90MG/DL BEFORE A MEAL OR MEDICATION. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE HIGHEST RESULT IN MEMORY (160) AND THE LOWEST NORMAL RESULT (70) IS LOCATED IN ZONE B/C. LAST 6 RESULTS IN MEMORY ARE 152MG/DL, 149MG/DL, 160MG/DL, 138MG/DL, 110MG/DL AND 161MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636811 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PP1576

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR