BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 4122521 · Received September 22, 2014

    Report

    Report Number
    1052693-2014-00355
    Event Type
    Malfunction
    Date Received
    September 22, 2014
    Date of Event
    August 26, 2014
    Report Date
    December 23, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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: STRIP ISSUE OR USER HAS HIGH GLUCOSE VALUE. PRODUCT CODES UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULTS READING "HI". CUSTOMER NORMALLY IS IN THE 265MG/DL RANGE. PERFORMED BACK TO BACK BLOOD TESTS - 386MG/DL AND 403MG/DL. LAST 5 RESULTS IN MEMORY WERE 543MG/DL, "HI", "HI", 269MG/DL, 235MG/DL. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULTS READING "HI". CUSTOMER NORMALLY IS IN THE 265MG/DL RANGE. PERFORMED BACK TO BACK BLOOD TESTS -386MG/DL AND 403MG/DL. LAST 5 RESULTS IN MEMORY WERE 543MG/DL, "HI", "HI", 269MG/DL, 235MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587516 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RP4257

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR