BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 1241660 · Received November 19, 2008

    Report

    Report Number
    1823260-2008-08571
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    November 13, 2008
    Report Date
    November 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS FOR SUSPECT DEVICE IN COAGUCHEK XS SYSTEM 1. REFERENCE MEDWATCH WITH A1 FOR SUSPECT DEVICE IN COAGUCHEK XS SYSTEM 2.

    Description of Event or Problem · 1

    CALLER STATES THE PT TESTED 4.3 INR ON COAGUCHEK XS SYSTEM 1 AND 3.0 INR ON COAGUCHEK XS SYSTEM 2 DURING DUPLICATE TESTING. NO ACTION TAKEN ON DEVICE RESULT. 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 20165635

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR AVALIDE- 300MG/DAY| PRILOSEC- 20MG/DAY| SIMVASTATIN- 40MG/DAY| ACTOS- 30MG/DAY