BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 1243239 · Received November 7, 2008

    Report

    Report Number
    1823260-2008-08245
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 9, 2008
    Report Date
    November 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED A RESULT OF 3.7 INR ON THE COAGUCHEK XS SYSTEM AND 2.8 INR ON A COMPARISON LAB. NO TREATMENT INFO PROVIDED. 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 20161631

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK