BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 6662999 · Received June 21, 2017

    Report

    Report Number
    MW5070590
    Event Type
    Malfunction
    Date Received
    June 21, 2017
    Date of Event
    June 20, 2017
    Report Date
    June 21, 2017
    Manufacturer
    TRIVDIA HEALTH
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM A TYPE 2 DIABETIC, I TEST FOR GLUCOSE LEVELS USING THE TRUE METRIX STRIPS MANUFACTURED BY TRIVIDA HEALTH OF (B)(6). THE TEST LEVEL VARIES CONSIDERABLY MORE THAN THE STATED PERCENTAGE IN THE PACKAGE INSERT. TODAY THE LEVELS TESTED WITHIN MINUTES WERE 203, 282, 212, 246. THESE LEVELS DICTATE THE AMOUNT OF INSULIN I TAKE AND COULD RESULT IN AN OVERDOSE. I HAVE TESTED MULTIPLE TIMES ON VARIOUS OTHER DAYS WITH SIMILAR RESULTS. IS THE PRODUCT COMPOUNDED: YES. IS THE PRODUCT OVER-THE-COUNTER: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439988 TRUE METRIX BLOOD GLUCOSE TEST STRIPS NBW TRIVDIA HEALTH VARIOUS

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other