BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 1767052 · Received October 19, 2007

    Report

    Report Number
    1823260-2007-09155
    Event Type
    Malfunction
    Date Received
    October 19, 2007
    Date of Event
    October 11, 2007
    Report Date
    October 19, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K974569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS THE PATIENT TESTED >8.0 INR AND >8.0 INR ON THE COAGUCHEK S SYSTEM AND 6.1 INR ON A COMPARISON LAB. CALLER STATES BASED ON THE LAB RESULT THE COUMADIN WAS HELD AND THE PATIENT WAS GIVEN A SMALL ORAL DOSE OF VITAMIN K TO TAKE AT HOME. CALLER STATES THE PATIENT WILL RETURN FOR TESTING BEFORE STARTING COUMADIN AGAIN. 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 617A A11

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR COUMADIN - 5 MG DAILY