BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX AIR

    MDR report key: 6147381 · Received December 2, 2016

    Report

    Report Number
    MW5066539
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Date of Event
    November 30, 2016
    Report Date
    December 2, 2016
    Manufacturer
    TRIVIDIA HEALTH INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE A TRUE METRIX AIR BLOOD GLUCOSE MEASUREMENT DEVICE SN (B)(4) WITH TRUE METRIX TEST STRIPS LOT CODE MT1852 DATE: 12/17/2017. ON (B)(6) 2016 I MADE A MEASUREMENT AT 1:54 PM OF 84 MG/DL. IT DIDN'T THINK IT WAS CORRECT AND MADE ANOTHER MEASUREMENT AT 1:56 PM OF 173 MG/DL. OBVIOUSLY THIS DIDN'T MAKE SENSE AND MADE TWO MEASUREMENTS WITH MY BAYER USB DEVICE AND GOT 119 AND 128 MG/DL RESPECTIVELY. USING THE SAME TRUE METRIX DEVICE AND LOT CODE OF TEST STRIPS LATER THE SAME DAY I MEASURED AT 5:48PM 193 MG/DL, AT 5:48 PM 170 MG/DL, AT 9:25 PM 230 MG/DL, AND AT 9:28 PM 172 MG/DL. OBVIOUSLY THESE MEASUREMENTS ARE POOR AND ARE LIKELY DUE TO A PROBLEM WITH THE METER OR THE TEST STRIPS. I HAVE CONTACTED TRIVIDIA HEALTH INC. WITH SAME INFORMATION AND WILL BE RETURNING THE METER AND TEST STRIPS TO THEM NEXT WEEK WHEN I GET A REPLACEMENT METER AND TEST STRIPS FROM THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793875 TRUE METRIX AIR TRUE METRIX AIR NBW TRIVIDIA HEALTH INC. TRUE METRIX AIR
    793876 TRUE METRIX TEST STRIPS TRUE METRIX TEST STRIPS NBW TRIVIDIA HEALTH INC. MT1852

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR