BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 1336109 · Received March 9, 2009

    Report

    Report Number
    1823260-2007-04995
    Event Type
    Malfunction
    Date Received
    March 9, 2009
    Date of Event
    May 25, 2007
    Report Date
    June 8, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K062925
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES:DICYCLOMINE - 2006 40MG/DAYPLUOXCINE - 2006 20MG/DAYHYDROCODONE -2007 5-100MG/5MLLIPITOR -2006 40MG/DAYLISINOPRIL - 2007 10MG/DAYMAGNESIUM - 2007 400MG/AS DIRECTEDMUSE - 2006 1000 MCGNITROGLYCERIN - 2006 0.4MGNORVASC- 10MG/DAYPOTASSIUM CHLORIDE - 2007 20 MEQ/DAYRANITIDINE - 2006 150 MG/DAYTOPROL XL - 2007 50 MG/DAYTRICOR -2006 145 MG/DAYZARAXOLYN - 2007 2.5 MG/ZETIA - 2007 10MG/DAY

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED 2.8 INR ON THE COAGUCHEK SYSTEM AND 2.1 INR ON A COMPARISON LAB. COUMADIN WAS HELD FOR 2 DAYS, HOWEVER NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK XS SYSTEM PROTHROMBIN TIME TEST STRIP JPA ROCHE DIAGNOSTICS 20152431

    Patients

    Seq Age Sex Outcome Treatment
    1 DEMADEX 20MG/DAY| WARFARIN 3MG/3 DAYS| WARFARIN 2MG/4 DAYS