BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 4251125 · Received November 5, 2014

    Report

    Report Number
    1052693-2014-00492
    Event Type
    Malfunction
    Date Received
    November 5, 2014
    Date of Event
    October 7, 2014
    Report Date
    November 5, 2014
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT BLOOD RESULT READING LOW. EXPECTED BLOOD GLUCOSE RANGE SHOULD BE 4.0-7.0 MMOL/L FASTING AND 5.0-10.0 MMOL/L 2 HOURS AFTER A MEAL. CONSUMER COMPARED RESULTS FROM THE METER (7.8MMOL/L) TO THE LAB INSTRUMENT (10.6MMOL/L). LAST 4 RESULTS FROM MEMORY WERE 10.0MMOL/L, 4.2MMOL/L, 10.8MMOL/L, AND 16.8MMOL/L. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE LOWEST RESULT IN MEMORY (4.2MMOL/L) AND THE LOWEST NORMAL RESULT (10.0MMOL/L) IS LOCATED IN ZONE B/C. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710160 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RR4446

    Patients

    Seq Age Sex Outcome Treatment
    1