BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE2GO

    MDR report key: 4253459 · Received November 12, 2014

    Report

    Report Number
    1052693-2014-00523
    Event Type
    Malfunction
    Date Received
    November 12, 2014
    Date of Event
    October 17, 2014
    Report Date
    December 11, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080710
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAS HIGH GLUCOSE VALUE. CORRECTION OF DATE OF EVENT :(B)(6) 2014.

    Description of Event or Problem · 1

    CONSUMER COMPLAINED OF BLOOD GLUCOSE RESULTS READING "HI". PERFORMED BLOOD TEST DURING THE TIME OF THE CALL WITH A RESULT OF 368MG/DL. RESULTS IN MEMORY WERE "HI", 314MG/DL. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINED OF BLOOD GLUCOSE RESULTS READING "HI". PERFORMED BLOOD TEST DURING THE TIME OF THE CALL WITH A RESULT OF 368MG/DL. RESULTS IN MEMORY WERE "HI", 314MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729546 TRUE2GO BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUE2GO PR1956

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR