BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 1338413 · Received March 11, 2009

    Report

    Report Number
    1823260-2007-05248
    Event Type
    Malfunction
    Date Received
    March 11, 2009
    Date of Event
    May 17, 2007
    Report Date
    June 15, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CONCOMITANT MEDICAL PRODUCTS QND THERAPY DATES: LIPITOR - 10MG; ADVAIR - 250/50 TWICE DAY; COREG - 50MG; ALTACE - 5MG; COUMADIN - 1.5MG/DAY; KCL - 10MEQ.

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED4.6 INR ON COAGUCHEK SYSTEM AND 7.0 INR ON A COMPARISON LAB. NO ACTION TAKEN ON DEVICE RESULT. 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 GJS ROCHE DIAGNOSTICS 20152431

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR DARVOCET| LANOXIN 0.125| DEMADEX 20MG