BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRUERESULT METER

    MDR report key: 5748020 · Received June 21, 2016

    Report

    Report Number
    MW5063004
    Event Type
    Other
    Date Received
    June 21, 2016
    Date of Event
    June 16, 2016
    Report Date
    June 21, 2016
    Manufacturer
    TRIVIDIA
    Product Code
    NBW
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT USED TRUERESULT METER WITH TRUEMETRIX STRIPS (SAME MANUFACTURER). THE STRIP FIT THE MACHINE AND LOOKED LIKE IT WAS WORKING AS USUAL (THIS WAS WITNESSED BY FNP AND MD AS WELL), BUT RECEIVED FALSE READING OF 23. VERIFIED BG ON HOSPITAL METER AND IT WAS 448.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391747 TRUERESULT METER TRUERESULT METER NBW TRIVIDIA
    391748 TRUEMETRIX STRIPS TRUEMETRIX STRIPS NBW TRUVIDIA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR