BEUDAMED
    FDA Adverse Event Death Summary report: N

    COAGUCHEK

    MDR report key: 190924 · Received October 6, 1998

    Report

    Report Number
    1823260-1998-00134
    Event Type
    Death
    Date Received
    October 6, 1998
    Date of Event
    June 1, 1998
    Report Date
    October 5, 1998
    Manufacturer
    ROUCHE DIAGNOSTICS
    Product Code
    JPA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT EXPERIENCED SIGNIFICANT WEIGHT LOSS, DIARRHEA, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, ASTHMA AND CARDIOMYOPATHY OVER THE LAST TWO WEEKS OF HER LIFE. THREE DAYS BEFORE INCIDENT, INR TESTED 7.6 AND 6.7. PRESCRIBED AND TOOK VITAMIN K AND STOPPED TAKING COUMADIN. TWO DAYS LATER INR WAS 1.6, NEXT DAY PT DIED. CONTROLS RUN EACH MONTH AND ALL ARE WITHIN RANGE. PT TESTED ON SEVERAL DIFFERENT INSTRUMENTS AND REPORTER FEELS THAT THE DEVICE IS NOT AT FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK COAGULATION MONITORING SYSTEM JPA ROUCHE DIAGNOSTICS * 078

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death