BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4190129 · Received September 18, 2014

    Report

    Report Number
    1052693-2014-00341
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 23, 2014
    Report Date
    December 23, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USE ERROR (REUSED STRIPS, POOR FILL, INACCURATE REFERENCE). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW CONTROL TEST RESULTS. PERFORMED CONTROL TEST, RESULT WAS 64 MG/DL, OUTSIDE OF THE REQUIRED CONTROL RANGE OF 31-61 MG/DL. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE CONTROL RESULT GIVEN (64) AND THE LOWEST RESULT THAT COULD BE CORRECTLY OBTAINED (31) IS LOCATED IN ZONE B/C. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW CONTROL TEST RESULTS. PERFORMED CONTROL TEST, RESULT WAS 64 MG/DL, OUTSIDE OF THE REQUIRED CONTROL RANGE OF 31-61 MG/DL. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE CONTROL RESULT GIVEN (64) AND THE LOWEST RESULT THAT COULD BE CORRECTLY OBTAINED (31) IS LOCATED IN ZONE B/C. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578031 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR1796

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR