BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 1181546 · Received September 25, 2008

    Report

    Report Number
    1823260-2008-07159
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 25, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED 2.4 INR TWICE DURING DUPLICATE TESTING ON THE COAGUCHEK XS SYSTEM AND A COMPARISON LAB RETURNED AS 1.6 INR AND 1.7 INR. NO ACTION TAKEN ON DEVICE RESULTS. 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 STRIPS - GJS GJS ROCHE DIAGNOSTICS 20164031

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR DIGOXIN - 0.25MG/DAY| COUMADIN 5MG/DAY| CARDIZEM - 360MG/DAY| ACCUPRIL - 20MG/DAY| PROTONIX 40MG/DAY| CELEBREX 200MG/DAY