BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 1241641 · Received November 19, 2008

    Report

    Report Number
    1823260-2008-08587
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    November 17, 2008
    Report Date
    November 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K974569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THE PT TESTED 5.9 INR ON THE COAGUCHEK S SYSTEM AND 3.7 INR ON A COMPARISON LAB. NO TREATMENT INFO PROVIDED. 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 S SYSTEM PROTHROMBIN TIME TEST STRIPS - JPA JPA ROCHE DIAGNOSTICS 758A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR COUMADIN - 7.5MG/1DAY