BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 1770613 · Received October 25, 2007

    Report

    Report Number
    1823260-2007-09299
    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
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS FOR SUSPECT DEVICE IN COAGUCHEK S SYSTEM 2. (B)(4).

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED EITHER 6.9 INR OR 6.4 INR ON COAGUCHEK S SYSTEM 1 AND EITHER 4.3 INR OR 4.9 INR ON COAGUCHEK SYSTEM 2 DURING DUPLICATE TESTING. MEDICATION WAS CHANGED BASED ON LOWER RESULT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE; HOWEVER, STRIPS ARE 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 580A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK