BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROCHE

    MDR report key: 777897 · Received November 6, 2006

    Report

    Report Number
    MW1040880
    Event Type
    Injury
    Date Received
    November 6, 2006
    Date of Event
    October 8, 2006
    Report Date
    November 3, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I TEST MY BLOOD AT HOME WITH A ROCHE COAGUCHEK MACHINE AND TEST STRIPS. I RECEIVED A LETTER FROM WHERE I PURCHASED THE TEST STRIPS SAYING THAT THERE WAS A RECALL OF TEST STRIPS #3116239- DUE TO "POTENTIAL FOR ERRONEOUS TEST RESULTS DUE TO INSUFFICIENT ACTIVE INGREDIENT IN THE TEST STRIP" AND MAY HAVE A "POTENTIAL FOR FALSELY HIGH RESULTS." I RECENTLY HAVE HAD SEVERAL HIGH TO VERY HIGH INR RESULTS. I STOPPED MY WARFARIN AS PER MY DOCTOR'S INSTRUCTIONS AND RETESTED A FEW DAYS LATER. FOR EXAMPLE MY INR WAS 4.7 AND 2 DAYS LATER MY INR WAS 2.0. I AM NOT SURE NOW IF I SHOULD HAVE ADJUSTED MY ANTI-COAGULANT. OF COURSE MY DOCTOR WAS UNAWARE AT THE TIME THAT THERE WOULD BE A RECALL OF THE TEST STRIPS. NOW I HAVE NO TEST STRIPS TO CHECK MY INR. SUPPLIER COULD NOT TELL ME WHEN NEW, REPLACEMENT TEST STRIPS WOULD BE AVAILABLE. I WANTED TO REPORT THIS TO THE FDA. SUPPLIER SAID THAT THERE WAS ONLY ONE ADVERSE EVENT, BUT I THINK THAT THERE ARE MORE, LIKE MYSELF. SUPPLIER WOULD NOT TAKE THIS INFORMATION THAT I AM RELATING TO YOU NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROCHE COAGUCHEK PT TEST JPA ROCHE DIAGNOSTICS * 279A G12

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Disability