BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 1780644 · Received September 27, 2007

    Report

    Report Number
    1823260-2007-08438
    Event Type
    Malfunction
    Date Received
    September 27, 2007
    Date of Event
    August 7, 2007
    Report Date
    September 27, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS THE PT TESTED 2.4 INR ON THE COAGUCHEK XS SYSTEM AND 1.4 INR ON A COMPARISON LAB. NO ACTION TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK XS SYSTEM PROTHROMBIN TIME TEST STRIPS - GJS GJS ROCHE DIAGNOSTICS 2015231

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK COUMADIN - 5MG SIX DAYS WEEKLY| COUMADIN - 7.5MG ON FRIDAYS