BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEBALANCE

    MDR report key: 4110735 · Received September 16, 2014

    Report

    Report Number
    1052693-2014-00317
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 16, 2014
    Report Date
    December 21, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K090495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT NUMBER: (B)(4). NO PRODUCT YET RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: STRIP ISSUE OR USER HAS HIGH GLUCOSE VALUE. CORRECTION OF 510(K): (B)(4).

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "HI." LAST 5 BLOOD RESULTS IN MEMORY: HI, HI, HI, 487 MG/DL, 434 MG/DL. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "HI". LAST 5 BLOOD RESULTS IN MEMORY: HI, HI, HI, 487MG/DL, 434MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571916 TRUEBALANCE BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUBALANCE BR4345

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR