BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE BALANCE

    MDR report key: 3802504 · Received February 21, 2014

    Report

    Report Number
    1052693-2014-00141
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    April 15, 2014
    Report Date
    November 25, 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

    (B)(4). NO PRODUCT YET RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT RETURNED. INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD AN INACCURATE REFERENCE. CORRECTION OF PMA/510(K)#: K090495.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT HIGH BLOOD RESULTS. CALLER NORMALLY RANGES FROM 130-140MG/DL. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE HIGHEST RESULT IN MEMORY (350) AND THE LOWEST NORMAL RESULT (130) IS LOCATED IN ZONE C. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT HIGH BLOOD RESULTS. CALLER NORMALLY RANGES FROM 130-140MG/DL. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE HIGHEST RESULT IN MEMORY (350) AND THE LOWEST NORMAL RESULT (130) IS LOCATED IN ZONE C. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111674 TRUE BALANCE BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUBALANCE BP4099

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR