BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 1770612 · Received October 25, 2007

    Report

    Report Number
    1823260-2007-09303
    Event Type
    Malfunction
    Date Received
    October 25, 2007
    Date of Event
    October 1, 2007
    Report Date
    October 25, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K974569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED >8.0 INR ON THE COAGUCHEK S SYSTEM AND 6.01 INR ON A COMPARISON LAB. COUMADIN ADJUSTED BASED ON LAB RESULT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM; HOWEVER, STRIPS UNAVAILABLE FOR RETURN. REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK S SYSTEM PROTHROMBIN TIME TEST STRIPS - JPA JPA ROCHE DIAGNOSTICS 586A-G17

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK