BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4200156 · Received October 21, 2014

    Report

    Report Number
    1052693-2014-00439
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 18, 2014
    Report Date
    December 15, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    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.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT HIGH BLOOD RESULTS. CUSTOMER NORMAL RESULTS ARE 110-125 MG/DL. PERFORMED BACK TO BACK BLOOD TESTS WITH RESULTS OF 210 AND 211 MG/DL. CUSTOMER STATES HE TESTED BEFORE HE TOOK INSULIN AND IT WAS 210 MG/DL, THEN WAITED 2 HOURS LATER AND TESTED AGAIN AND RECEIVED A RESULT OF 210 MG/DL. BAED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE RESULT IN QUESTION (210) AND THE LOWEST NORMAL RESULT (110) IS LOCATED IN ZONE B/C. LAST 5 RESULTS IN MEMORY ARE 128 MG/DL, 302 MG/DL, 124 MG/DL, 164 MG/DL AND 175 MG/DL. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT HIGH BLOOD RESULTS. CUSTOMER NORMAL RESULTS ARE 110-125MG/DL. PERFORMED BACK TO BACK BLOOD TESTS WITH RESULTS OF 210 AND 211MG/DL. CUSTOMER STATES THAT HE TESTED BEFORE HE TOOK INSULIN AND IT WAS 210MGD/L, THEN WAITED 2 HOURS LATER AND TESTED AGAIN AND RECEIVED A RESULT OF 210MG/DL. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE RESULT IN QUESTION (210) AND THE LOWEST NORMAL RESULT (110) IS LOCATED IN ZONE B/C. LAST 5 RESULTS IN MEMORY ARE 128MG/DL, 302MG/DL, 124MG/DL, 164MG/DL, AND 175MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670367 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR1811

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR