BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4110148 · Received September 11, 2014

    Report

    Report Number
    1052693-2014-00306
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Date of Event
    August 14, 2014
    Report Date
    December 21, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    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 OR USER REUSED TEST STRIP OR USER'S TEST STRIP HAD POOR FILL. PRODUCT CODES UPDATED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD RESULTS. CALLER NORMALLY IS AROUND 90-118MG/DL ONE HOUR AFTER MEALS. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE LOWEST RESULT GIVEN (60) AND THE NORMAL RESULT (118) IS LOCATED IN ZONE B/C. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD RESULTS. CALLER NORMALLY IS AROUND 90-118MG/DL ONE HOUR AFTER MEALS. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE LOWEST RESULT GIVEN (60) AND THE NORMAL RESULT (118) IS LOCATED IN ZONE B/C. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563265 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PP1135

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR