BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 1022325 · Received March 27, 2008

    Report

    Report Number
    1823260-2008-02804
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    January 2, 2008
    Report Date
    March 27, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED RESULT OF 4.1 INR ON HER COAGUCHEK XS SYSTEM AND 2.5 INR ON A PROFESSIONAL USE COAGUCHEK S SYSTEM DURING DUPLICATE TESTING. 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 JPA ROCHE DIAGNOSTICS 20155136

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SEROXAT 3 MONTHS AGO| WARFARIN 10MG/DAY| CALCHEW| FUROSEMIDE