BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 1780362 · Received September 12, 2007

    Report

    Report Number
    1823260-2007-07956
    Event Type
    Malfunction
    Date Received
    September 12, 2007
    Date of Event
    July 10, 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
    ID, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS PT TESTED 1.7 INR ON THE COAGUCHEK S SYSTEM AND 2.48 INR ON A COMPARISON LAB. NO ACTION TAKEN ON DEVICE RESULT. NO ADVERSE EVENT 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 528A-F2

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR LISINOPRIL - 20MG/DAY| KLOR-CON - 40MG/DAY| FUROSEMIDE - 40MG/DAY| LANOXIN - 0.125MG/DAY| COREG - 50MG/DAY| COUMADIN - 2MG/DAY| PREVACID - 500MG/DAY