BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 1002715 · Received February 8, 2008

    Report

    Report Number
    1823260-2008-01408
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    December 12, 2007
    Report Date
    February 8, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K974569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT 2: COUMADIN WAS ADJUSTED BASED ON LAB RESULT. MECHANICAL HEART VALVE. COUMADIN: 28MG/WEEK. PATIENT 3: COUMADIN WAS ADJUSTED BASED ON LAB RESULT. MECHANICAL HEART VALVE, COUMADIN: 39MG/WEEK.

    Description of Event or Problem · 1

    CALLER REPORTS DURING A CORRELATION STUDY THE FOLLOWING COAGUCHEK S/LABORATORY RESULTS WERE OBTAINED: PATIENT 1) 7.1 INR/4.6 INR. PATIENT 2) 6.1 INR/4.1 INR. PATIENT 3) 6.1 INR/4.1 INR. NO ACTION TAKEN ON DEVICE 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 ROCHE DIAGNOSTICS 599A-H6

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK COUMADIN - 45MG/WEEK