BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 1771971 · Received September 18, 2007

    Report

    Report Number
    1823260-2007-08152
    Event Type
    Malfunction
    Date Received
    September 18, 2007
    Date of Event
    August 28, 2007
    Report Date
    September 18, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED 2.5 INR ON THE COAGUCHEK XS SYSTEM AND 2.0 INR ON A COMPARISON LAB. COUMADIN WAS ADJUSTED BASED ON LAB VALUE. 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 20152731

    Patients

    Seq Age Sex Outcome Treatment
    1 NA COUMADIN - 3MG/DAY| TOPROL XL - 25 MG/DAY| HYDROCHLOROTHIAZIDE - 25MG/DAY