BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 1780356 · Received September 12, 2007

    Report

    Report Number
    1823260-2007-07954
    Event Type
    Malfunction
    Date Received
    September 12, 2007
    Date of Event
    August 17, 2007
    Report Date
    September 12, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K974569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS THE PT TESTED 8.0 INR ON THE COAGUCHEK S SYSTEM AND 4.3 INR ON A COMPARISON LAB. COUMADIN WAS HELD UNTIL LAB RESULTS WERE RECEIVED. NO ADVERSE EVENTS REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK S SYSTEM PROTHROMBIN TIME TEST STRIPS - JPA JPA ROCHE DIAGNOSTICS 569A-G15

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR MEDERAL DOSE PACK| COUMADIN - 3.75MG/DAY MWF, 2.5MG/DAY OTHER| SYMASTIN - 20MG/DAY