BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 1022322 · Received March 27, 2008

    Report

    Report Number
    1823260-2008-02801
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    March 20, 2008
    Report Date
    March 27, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED >8.0 INR ON THE COAGUCHEK XS SYSTEM AND 1.4 INR ON A COMPARISON LAB. NO ACTION TAKEN ON DEVICE RESULT, COUMADIN ADJUSTED BASED ON LAB RESULT. 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 XS SYSTEM PROTHROMBIN TIME TEST STRIP - GJS GJS ROCHE DIAGNOSTICS 20157931

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK METROGEL| ADVAIR| SINGULAR| FOLIC ACID| MULTI VITAMIN| COUMADIN 4MG/DAY