BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4200142 · Received October 21, 2014

    Report

    Report Number
    1052693-2014-00429
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 16, 2014
    Report Date
    January 4, 2016
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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.

    Additional Manufacturer Narrative · 1

    PRODUCT NOT YET RETURNED FOR EVALUATION. (B)(4). MANUFACTURER ACKNOWLEDGES LATENESS OF THE REPORT, PER INTERNAL CORRECTIVE ACTION. THIS REPORT SHOULD HAVE BEEN IDENTIFIED AS REPORTABLE WITHIN 30 DAYS OF THE IDENTIFICATION (09/16/2014).

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD RESULTS. CALLER NORMALLY IS AROUND 104-115MG/DL. CUSTOMER PERFORMED BACK TO BACK BLOOD TESTS ON TRUERESULT AND TRUETRACK METERS WITH A RESULTS OF 74MG/DL AND 146MG/DL. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE LOWEST RESULT GIVEN (74) AND THE HIGHEST NORMAL RESULT (146) 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 104-115 MG/DL. CUSTOMER PERFORMED BACK TO BACK BLOOD TESTS ON TRUERESULT AND TRUETRACK METERS WITH A RESULT OF 74 MG/DL AND 146 MG/DL. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE LOWEST RESULT GIVEN *74) AND THE HIGHEST NORMAL RESULT (146) IS LOCATED IN ZONE B/C. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669968 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PP1625

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR