BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 1022329 · Received March 27, 2008

    Report

    Report Number
    1823260-2008-02808
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    March 21, 2008
    Report Date
    March 27, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K974569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED 1.3 INR ON THE COAGUCHEK S SYSTEM AND 1.18 INR ON A COMPARISON LAB. NO ACTION TAKEN ON DEVICE RESULT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK S SYSTEM PROTHROMBIN TIME TEST STRIP - JPA JPA ROCHE DIAGNOSTICS 656A-D3

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK