BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 1761114 · Received July 19, 2007

    Report

    Report Number
    1823260-2007-06299
    Event Type
    Malfunction
    Date Received
    July 19, 2007
    Date of Event
    July 5, 2007
    Report Date
    July 19, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K974569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS FOR SUSPECT DEVICE IN COAGUCHEK SYSTEM 2. REFERENCE MEDWATCH WITH (B)(4) FOR SUSPECT DEVICE IN COAGUCHEK SYSTEM 1.

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED 1.7 INR ON COAGUCHEK SYSTEM 1, AND 4.0 INR ON COAGUCHEK SYSTEM 2. NO ACTION TAKEN ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM 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 568A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA