BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE RESULT METER

    MDR report key: 5636625 · Received April 28, 2016

    Report

    Report Number
    MW5062102
    Event Type
    Injury
    Date Received
    April 28, 2016
    Date of Event
    January 1, 2012
    Manufacturer
    NIPRO DIAGNOSTICS - TRIVIDIA
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TRUE RESULT METER READS DIFFERENTLY; 30-50 PTS. I FELT WEAK AND SHAKY SO I TESTED MY BLOOD SUGAR USING TRUE RESULT METER AND TRUE TEST STRIPS GDH-PQQ SAID 80. I RETESTED USING ONE TOUCH ULTRA SAID I WAS 40. THIS HAPPENS OFTEN, THEN TRUE RESULT METER ERROR COMPANY SAID TO SEND METER BACK. THEY SENT REPLACEMENT TRUE RESULT METER AND TRUE TEST GDH-PQQ TEST STRIPS. I HAVE REPLACED TRUE RESULT METER AT LEAST 5-7 TIMES, EITHER WITH THE COMPANY OR MY (B)(6) COMPLAINING OF INACCURATE READINGS AND ERROR. I'VE TALKED WITH OTHERS HAVING SAME COMPLAINTS. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274151 TRUE RESULT METER RESULT METER NBW NIPRO DIAGNOSTICS - TRIVIDIA MO8055552 PS2614
    274152 TRUE TEST GDH-PQQ TEST STRIPS TEST STRIPS NBW NIPRO DIAGNOSTICS/TRIVIDIA HEALTH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization| L