BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 1181569 · Received September 25, 2008

    Report

    Report Number
    1823260-2008-07166
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 25, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED FOUR RESULTS OF 3.8 INR AND ONE RESULT OF 3.6 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 2.6 INR. NO TREATMENT INFORMATION PROVIDED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK XS SYSTEM PROTHROMBIN TIME TEST STRIP - NA GJS ROCHE DIAGNOSTICS 20158722

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK COPROXAMOL 325MG/DAY| WARFARIN 5MG/5DAYS