BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 1780319 · Received September 12, 2007

    Report

    Report Number
    1823260-2007-07964
    Event Type
    Malfunction
    Date Received
    September 12, 2007
    Date of Event
    August 27, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS PT TESTED 6.5 INR ON THE COAGUCHEK S SYSTEM AND 4.9 INR ON A COMPARISON LAB. CALLER IS UNSURE IF COUMADIN WAS CHANGED BASED ON COAGUCHEK SYSTEM 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 584A-I2

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR BUBROPRION XL - 300MG/DAY| VITAMINS| LYRICA - 75MG/DAY| AMBIEN CR - 12.5MG/DAY| PREDNISONE - 10MG/DAY| HYDROCODONE - AS NEEDED FOR PAIN| POTASSIUM - 10MEQ/DAY| LEXAPRO - 20MG/DAY| SPIRONOLACTONE - 50MG/DAY| REQUIP - 1MG/DAY| BISOPROLOL - 10MG/DAY| TORSEMIDE - 20MG/DAY| ALPRAZOLAM - 1MG/DAY| COUMADIN - 5MG/DAY SUN, M, W, TH, F, 2.5MG/DAY