BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX TEST STRIPS

    MDR report key: 6266583 · Received January 18, 2017

    Report

    Report Number
    MW5067352
    Event Type
    Injury
    Date Received
    January 18, 2017
    Date of Event
    October 28, 2016
    Report Date
    January 18, 2017
    Manufacturer
    TRIVIDIA HEALTH INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WHEN I USED MY LAST 3 BOTTLES OF TRUE METRIX TEST STRIPS (EACH OF THE BOTTLES HAS ABOUT 10 TO 20 STRIPS RETURNING AN ERROR) AND WHEN I CHANGE MY FINGER TO TEST THE NEXT STRIP, WILL SHOW MY READING. I CALLED THE COMPANY IN (B)(6) 2016 TO COMPLAIN ABOUT THIS PRODUCT. THE COMPANY DID NOT DO ANYTHING ABOUT THIS PROBLEM AND I WAS TOLD THEY DID NOT HAVE A PROBLEM. THE FDA HAS DONE A RECALL FROM THIS COMPANY BEFORE. THE WAY IT IS NOW, I RUN OUT OF TEST STRIPS BEFORE THE END OF THE MONTH EACH MONTH DUE TO THE TEST STRIPS GIVING ERROR REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43411 TRUE METRIX TEST STRIPS SYSTEM, TEST, BLOOD GLUCOSE NBW TRIVIDIA HEALTH INC. MT2062

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Disability ALLOPURINOL| ASPIRIN| ATORVASTATIN| CARVEDILOL| CLONAZEPAM| DILTIAZEM| FENOFIBRATE.| GABAPENTIN| GLIMEPIRIDE| HUMULIN R| ISOSORB| LISINOPRIL| METFORMIN| MORPHINE SULFATE| NITROSTAT| OMEPRAZOLE| PERCOCET| RX MEDS: FUROSEMIDE| SYMBICORT| VENTOLIN| XARELTO