BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE2GO

    MDR report key: 4172418 · Received October 9, 2014

    Report

    Report Number
    1052693-2014-00403
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Date of Event
    September 13, 2014
    Report Date
    December 15, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080710
    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:USER HAS LOW GLUCOSE VALUE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF "LO" BLOOD RESULTS. CALLER STATES NORMALLY RANGES SHOULD BE AROUND 120-140MG/DL. LAST 5 BLOOD RESULT IN MEMORY: "LO", "LO", "LO", 122MG/DL AND 83MG/DL. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF "LO" BLOOD RESULTS. CALLER STATES NORMALLY RANGES SHOULD BE AROUND 120-140MG/DL. LAST 5 BLOOD RESULT IN MEMORY: "LO", "LO", "LO", 122MG/DL AND 83MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636793 TRUE2GO BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUE2GO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR