BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 6121554 · Received November 19, 2016

    Report

    Report Number
    MW5066244
    Event Type
    Injury
    Date Received
    November 19, 2016
    Date of Event
    September 22, 2016
    Report Date
    November 19, 2016
    Manufacturer
    TRIVIDIA HEALTH
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS USING TRUE RESULT TO MEASURE MY BLOOD SUGAR LEVELS BECAUSE I WAS DIAGNOSED WITH PRE-DIABETES, THE NEW COMPANY NOW IT IS CALLED TRIVIDIA HEALTH AND THE PRODUCT NAME IS TRUE METRIX, THIS DEVICE IT IS USELESS, NEVER DISPLAYS THE CORRECT MEASUREMENT, THE REASON I KNOW THAT IS BECAUSE IF I TEST MY BLOOD 3 TIMES, IT GIVES ME A DIFFERENT READING EVERY TIME, NOT A SLIGHTLY DIFFERENT READING BUT HUGE DIFFERENT. I CHECKED THE REVIEWS FROM (B)(6). I TRIED TO CONTACT THIS COMPANY AND THE CUSTOMER SERVICE DOESN'T EXIST. IT IS ALWAYS BUSY YOU CAN STAY IN THE LINE FOR HOURS AND YOU WILL KEEP HEARING A RECORDING USING THE OLD TRICK THAT THEY ARE EXPERIENCING HIGH VOLUME OF CALLS. I WENT TO (B)(6) WHERE I GOT THIS PRODUCT AND THEY TOLD ME I HAVE TO CALL THE MFR. FROM WHAT I HAVE BEEN RESEARCHING ABOUT THIS COMPANY, EVERYTHING LOOKS FISHY, THEY JUST CARE ABOUT MAKING MONEY. IT IS SAD THAT THERE IS SO MUCH CORRUPTION TODAY, BUT PLAYING WITH PEOPLE'S HEALTH SHOULD BE PENALIZED. RIGHT NOW I HAVE NO OPTIONS, I CAN'T READ MY SUGAR UNLESS I BUY A REAL PRODUCT AND PAY FOR THE TEST STRIPS BECAUSE MY INSURANCE ONLY COVER THESE ONES. I DON'T KNOW IF THIS LETTER WILL BE LOST IN A PILE OF COMPLAINTS OR SOMEONE WHO CARES WILL HELP TO FIX THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766134 TRUE METRIX GLUCOSE TEST SYSTEM NBW TRIVIDIA HEALTH

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention BENICAR 40 MG| NADOLOL 40 MG| VITAMIN D