BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 1001810 · Received February 19, 2008

    Report

    Report Number
    1823260-2008-01704
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    January 23, 2008
    Report Date
    February 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER STATES THAT A LAB TO COAGUCHEK XS COMPARISON YIELDED RESULTS OF 4.5 INR AND 3.1 INR. IT IS UNCLEAR WHICH RESULT IS THE LAB OR CAOGUCHEK XS RESULT. THE PATIENT WAS ADVISED NOT TO DOSE COUMADIN BASED ON DEVICE RESULTS AFTER THIS COMPARISON. 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 - NA JPA ROCHE DIAGNOSTICS 20156032

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK WARFARIN