BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 1003458 · Received February 21, 2008

    Report

    Report Number
    1823260-2008-01756
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    February 8, 2008
    Report Date
    February 21, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED 7.5 INR ON THE COAGUCHEK XS SYSTEM AND 4.4 INR ON A COMPARISON LAB. NO ACTION TAKEN ON DEVICE RESULT, HOWEVER COUMADIN WAS HELD 2 DAYS BASED ON LAB 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 20158231

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR LIPITOR - 40MG/DAY| ASPIRIN - 325MG/DAY| VIAGRA - 100MG/AS NEEDED| RANITIDINE - 300MG/DAY| ANDRAGEL TESTRONE - 50MG/DAY| COREG - 6.25MG/DAY| METOPROLOL TARTRATE - 25MG/DAY| DIGITEK - 0.125MG/DAY| LOMOTIL - 2.5-0.025MG/AS NEEDED| COUMADIN - 10MG/DAY