BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 4172420 · Received October 9, 2014

    Report

    Report Number
    1052693-2014-00404
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Date of Event
    September 14, 2014
    Report Date
    December 15, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 HIGH BLOOD RESULTS. CUSTOMER NORMALLY IS 150MG/DL. LAST 5 RESULTS IN MEMORY: 302MG/DL, 597MG/DL, 205MG/DL, 361MG/DL, AND 442MG/DL. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE HIGHEST RESULT IN THE MEMORY (597) AND THE NORMAL RESULT (150) IS LOCATED IN ZONE C/D. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD RESULTS. CUSTOMER NORMALLY IS 150MG/DL. LAST 5 RESULTS IN MEMORY: 302MG/DL, 597MG/DL, 205MG/DL, 361MG/DL, AND 442MG/DL. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE HIGHEST RESULT IN THE MEMORY (597) AND THE NORMAL RESULT (150) IS LOCATED IN ZONE C/D. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636988 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RR4343

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR