BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 1771242 · Received February 15, 2008

    Report

    Report Number
    1823260-2008-01618
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 28, 2008
    Report Date
    February 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS FOR SUSPECT DEVICE IN COAGUCHEK XS SYSTEM. (B)(4)

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED 3.7 INR ON THE COAGUCHEK XS SYSTEM AND 2.5 INR ON THE COAGUCHEK S SYSTEM 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 20152231

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR LORCET - 7.5>650 AS NEEDED| BABY ASPIRIN - 81MG/DAY| CRESTOR - 10MG/DAY| COUMADIN - 6MG M/W/F, 5MG SUN/T/TH/SAT| STOOL SOFTENER