BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA 1650

    MDR report key: 459456 · Received May 6, 2003

    Report

    Report Number
    2432235-2003-00003
    Event Type
    Other
    Date Received
    May 6, 2003
    Date of Event
    April 1, 2003
    Report Date
    April 2, 2003
    Manufacturer
    JEOL, LTD.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OPERATOR WAS IN THE PROCESS OF ADDING A CONTROL SAMPLE TO THE CONTROL TRAY OF THE ADVIA 1650 INSTRUMENT AS INSTRUMENT WAS PERFORMING A WASH CYCLE. IN THE PROCESS THE OPERATOR CUT THEIR LEFT INDEX FINGER ON THE SAMPLE DILUTION PROBE, WHICH WAS IN MOTION AT THE TIME. THE OPERATOR BLED THEIR FINGER AND IRRIGATED THE WOUND WITH A DISINFECTANT. IN ADDITION, THEY WERE GIVEN A TETANUS TOXOID PLUS DIPHTERIA VACCINE AND THEIR BLOOD WAS TAKEN FOR CULTURE AND TESTING AS ADVISED IN THEIR LABORATORY PROCEDURES. NO EMERGENCY CARE WAS NECESSARY. THE INSTRUMENT GIVES A WARNING AGAINST ADDING ANYTHING WHILE THE INSTRUMENT IS RUNNING. THIS WARNING HAS TO BE ACKNOWLEDGE BY THE OPERATOR BEFORE THE INSTRUMENT WILL START. BAYER DIAGNOSTICS MANUFACTURING PERSONNEL CONCLUDES THAT THIS ISSUE WAS DUE TO THE OPERATOR NOT FOLLOWING APPROPRIATE WARNINGS AND INSTRUCTIONS FOR USE AND THERE IS NO NEED FOR FURTHER CORRECTIVE ACTION. FOR MEDICAL DEVICE REPORTING PURPOSES THIS EVENT IS CONSIDERED CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 1650 CLINICAL CHEMISTRY ANALYZER JJE JEOL, LTD. BAYER ADVIA 1650 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other