BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE2GO

    MDR report key: 4251132 · Received November 5, 2014

    Report

    Report Number
    1052693-2014-00500
    Event Type
    Malfunction
    Date Received
    November 5, 2014
    Date of Event
    October 12, 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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    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 LOW GLUCOSE VALUE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF "LO" BLOOD RESULTS. CALLER STATES NORMALLY RANGES SHOULD BE AROUND 160-170MG/DL. PERFORMED BACK TO BACK BLOOD TESTS AND BOTH RESULTED IN "LO" LAST 4 TESTS IN MEMORY: "LO", 154 MG/DL, 223 MG/DL, 294MG/DL. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF "LO" BLOOD RESULTS. CALLER STATES NORMALLY RANGES SHOULD BE AROUND 160-170MG/DL. PERFORMED BACK TO BACK BLOOD TESTS AND BOTH RESULTED IN "LO". LAST 4 BLOOD RESULT IN MEMORY: "LO", 154MG/DL, 223MG/DL, 294MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710269 TRUE2GO BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUE2GO PR1793

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR