BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 1770785 · Received September 5, 2007

    Report

    Report Number
    1823260-2007-07752
    Event Type
    Malfunction
    Date Received
    September 5, 2007
    Date of Event
    July 18, 2007
    Report Date
    September 5, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K974569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS THE PATIENT TESTED 5.8 INR ON COAGUCHEK S SYSTEM AND 3.7 INR ON A COMPARISON LAB ON 7/23. PATIENT TESTED 6.5 INR ON THE COAGUCHEK S SYSTEM AND 4.5 INR ON A COMPARISON LAB ON 7/27. NO ACTION TAKEN BASED ON VALUES. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK S SYSTEM PROTHROMBIN TIME TEST STRIPS - JPA JPA ROCHE DIAGNOSTICS 571A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA TYLENOL - AS NEEDED, DOSE UNK