BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4202979 · Received September 18, 2014

    Report

    Report Number
    1052693-2014-00337
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 22, 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
    MI, 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 HAD AN INACCURATE REFERENCE OR USER'S TEST STRIP HAD POOR FILL.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD RESULTS. RESULTS FROM THE TRUERESULT METER WERE COMPARED OT THE HOSPITAL METER: 206 MG/DL VS 259 NG/DL, 96 MG/DL VS 251 MG/DL, 169 MG/DL VS. 218 MG/DL, 176 MG/DL VS. 214 MG/DL. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE LOWEST RESULT GIVEN (96) AND THE NORMAL RESULT (251) IS LOCATED IN ZONE C. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD RESULTS. RESULTS FROM THE TRUERESULT METER WERE COMPARED TO THE HOSPITAL METER: 206MG/DL VS. 259MG/DL, 96MG/DL VS, 251MG/DL, 169MG/DL VS. 218MG/DL, 176MG/DL VS. 214MG/DL. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE LOWEST RESULT GIVEN (96) AND THE NORMAL RESULT (251) IS LOCATED IN ZONE C. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578895 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR1887

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR