BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 6993184 · Received November 1, 2017

    Report

    Report Number
    1000113657-2017-01885
    Event Type
    Malfunction
    Date Received
    November 1, 2017
    Date of Event
    October 9, 2017
    Report Date
    November 1, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00052569138557
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. TEST STRIPS NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-20-USER'S TEST STRIP HAD POOR STORAGE (KITCHEN). (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771913 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MU2422 00052569138557

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR