BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 1060050 · Received June 12, 2008

    Report

    Report Number
    1823260-2008-04674
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    April 28, 2008
    Report Date
    June 12, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT OCCURRED IN ANOTHER COUNTRY.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY COMPARED HIS COAGUCHEK XS SYSTEM TO A LAB AND RECEIVED A VARIANCE OF 1.0 INR. NO TREATMENT INFO PROVIDED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK XS SYSTEM PROTHROMBIN TIME TEST STRIP-NA JPA ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK