BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 4110118 · Received September 11, 2014

    Report

    Report Number
    1052693-2014-00304
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Date of Event
    August 13, 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
    OH, US
    Reporter Occupation
    OTHER

    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 BLOOD RESULTS READING "HI". LAST 5 RESULTS WERE 587 MG/DL, 385 MG/D:L, "HI", "487 MG/DL, 198MG/DL. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULTS READING "HI". LAST 5 RESULTS WERE 587 MG/DL, 385 MG/D:L, "HI", "487 MG/DL, 198MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563132 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RR4408

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR