BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 4253457 · Received November 12, 2014

    Report

    Report Number
    1052693-2014-00518
    Event Type
    Malfunction
    Date Received
    November 12, 2014
    Date of Event
    October 15, 2014
    Report Date
    December 11, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 HAS HIGH GLUCOSE VALUE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULTS READING "HI". CONSUMER DECLINED TO PERFORM BLOOD TEST AT THE TIME OF THE CALL. LAST 5 RESULTS IN MEMORY WERE 366MG/DL, "HI", 78MG/DL, 163MG/DL, AND 140MG/DL. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULTS READING "HI". CONSUMER DECLINED TO PERFORM BLOOD TEST AT THE TIME OF THE CALL. LAST 5 RESULTS IN MEMORY WERE 366MG/DL, "HI", 78MG/DL, 163MG/DL, AND 140MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729674 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RR4387

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR