BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4172424 · Received October 9, 2014

    Report

    Report Number
    1052693-2014-00401
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Date of Event
    September 13, 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
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT HIGH BLOOD RESULTS. CUSTOMER NORMAL RESULTS ARE 79-131 MG/DL. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE HIGHEST RESULT IN MEMORY (454) AND THE LOWEST NORMAL RESULT (79) IS LOCATED IN ZONE D. LAST 5 RESULTS IN MEMORY ARE 454 MG/DL, 311 MG/DL, 237 MG/DL, AND 282 MG/DL. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT HIGH BLOOD RESULTS. CUSTOMER NORMAL RESULTS ARE 79-131MG/DL. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE HIGHEST RESULT IN MEMORY (454) AND THE LOWEST NORMAL RESULT (79) IS LOCATED IN ZONE D. LAST 5 RESULTS IN MEMORY ARE 454MG/DL, 103MG/DL, 311MG/DL, 237MG/DL, AND 282MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636963 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR1814

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR