BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 1243249 · Received November 7, 2008

    Report

    Report Number
    1823260-2008-08235
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 24, 2008
    Report Date
    November 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K974569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THE PT TESTED >8.0 INR ON THE COAGUCHEK S SYSTEM AND 5.5 INR ON A COMPARISON LAB. VITAMIN K WAS ADMINISTERED BASED ON LAB RESULT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM, HOWEVER, STRIPS ARE UNAVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK S SYSTEM PROTHROMBIN TIME TEST STRIPS- JPA JPA ROCHE DIAGNOSTICS 758A-H13

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR VYTORIN| PERCOCET| AMARYL| METFORMIN ER| NEXIUM| COUMADIN-5MG/1DAY| ALLOPURINOL| SOTALOL| COLCHICINE| LOTREL| TRICOR| CELEBREX