BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEBALANCE

    MDR report key: 4110730 · Received September 16, 2014

    Report

    Report Number
    1052693-2014-00327
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 19, 2014
    Report Date
    December 24, 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). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION:STRIP ISSUE. PRODUCT CODES UPDATED. CORRECTION OF 510(K): K090495.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT BLOOD RESULT READING "HI." CALLER USUALLY GETS RESULTS AROUND 100-135 MG/DL. CUSTOMER PERFORMED BACK TO BACK BLOOD RESTS AND OBTAINED A 517 MG/DL AND "HI." LAST FIVE RESULTS IN MEMORY WERE 457 MG/DL, 337 MG/DL, "HI", 567 MG/DL, 571 MG/DL. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT BLOOD RESULT READING "HI". CALLER USUALLY GETS RESULTS AROUND 100-135MG/DL. CUSTOMER PERFORMED BACK TO BACK BLOOD TESTS AND OBTAINED A 517MG/DL AND "HI". LAST FIVE RESULTS IN MEMORY WERE 457MG/DL, 337MG/DL, "HI", 567MG/DL, 571MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572034 TRUEBALANCE BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUBALANCE BN4023

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR