BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS LAB AUTOMATION SYSTEM

    MDR report key: 982398 · Received January 18, 2008

    Report

    Report Number
    3004148966-2008-00001
    Event Type
    Malfunction
    Date Received
    January 18, 2008
    Date of Event
    December 17, 2007
    Report Date
    January 18, 2008
    Manufacturer
    OLYMPUS DIAGNOSTICA LAB-AUTOMATION GMBH
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT APPEARS TO BE AN ISOLATED MALFUNCTION DUE TO USER ERROR. IT STATES IN THE USER GUIDE THAT THE COVER IS TO BE CLOSED WHEN OPERATING THE SYSTEM. POST INFECTIOUS MATERIAL EXPOSURE PRACTICES WERE FOLLOWED (BLOOD SAMPLES DRAWN FROM THE OPERATOR WITH NEGATIVE RESULTS) AS A PRECAUTION. ADDITIONAL BLOOD SAMPLES WILL BE DRAWN FROM THE OPERATOR IN A 6 MONTHS. OLYMPUS IS CONTINUING TO EVALUATE THIS EVENT. IF ACTION IS INDICATED OR OTHER SIGNIFICANT INFO IS REC'D, A FOLLOW-UP TO THIS EVENT WILL BE FILED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A LID COVER FELL ON AN OPERATOR WHILE LOADING SAMPLES. THE SAMPLES REPORTEDLY SPLASHED ON THE OPERATOR'S FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS LAB AUTOMATION SYSTEM CALCULATOR/DATA PROCESSING MODULE JQP OLYMPUS DIAGNOSTICA LAB-AUTOMATION GMBH OLA2500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA