BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEBALANCE

    MDR report key: 4239150 · Received October 31, 2014

    Report

    Report Number
    1052693-2014-00473
    Event Type
    Malfunction
    Date Received
    October 31, 2014
    Date of Event
    October 2, 2014
    Report Date
    December 11, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K090495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    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. PRODUCT CODES UPDATED. CORRECTION OF 510(K) # K090495.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT HIGH BLOOD RESULTS. CALLER USUALLY GETS RESULTS AROUND 159MG/DL. THE LAST RESULTS IN MEMORY: 467 MG/DL, 446 MG/DL, 494 MG/DL, 232 MG/DL AND 374 MG/DL. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE HIGHEST RESULT IN MEMORY (494) AND THE NORMAL RESULT (159) IS LOCATED IN ZONE C. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT HIGH BLOOD RESULTS. CALLER USUALLY GETS AROUND 159MG/DL. THE LAST RESULTS IN MEMORY: 467 MG/DL, 446 MG/DL, 494 MG/DL, 232 MG/DL AND 374 MG/DL. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE HIGHEST RESULT IN MEMORY (494) AND THE NORMAL RESULT (159) IS LOCATED IN ZONE C. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698385 TRUEBALANCE BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUBALANCE BP4303

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR