BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA 1650

    MDR report key: 531357 · Received June 24, 2004

    Report

    Report Number
    2432235-2004-00007
    Event Type
    Other
    Date Received
    June 24, 2004
    Date of Event
    May 9, 2004
    Report Date
    May 24, 2004
    Manufacturer
    JEOL, LTD
    Product Code
    JJC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2004 A HEALTHCARE PROFESSIONAL AT A MEDICAL CENTER REPORTED THAT 2 WKS EARLIER AN OPERATOR OF THE ADVIA 1650 CHEMISTRY ANALYZER WAS SCRAPED ACROSS THE BACK OF THEIR RIGHT HAND BY THE INSTRUMENT'S SAMPLE DILUTION PROBE (DPP). AT THIS SITE THE ADVIA 1650 IS PART OF A LAB AUTOMATION SYSTEM, THIS INCIDENT HAPPENED AS THE OPERATOR WAS TRYING TO RIGHT A SAMPLE PUCK (HOLDER) THAT WAS TIPPED ON ITS SIDE AND WAS STUCK IN THE TURN WHEEL AT THE SAMPLING AREA FOR THE ADVIA 1650. THE SAMPLE PROBE ON THE ADVIA 1650 SWUNG ACROSS AND SCRAPED THE TOP OF THEIR RIGHT HAND. THE ADVIA 1650 WAS IN "WATCH" MODE IN WHICH IT AWAITS FOR INFO FROM THE LAB AUTOMATION SOFTWARE ON WHEN THE NEXT SAMPLE IS COMING AND WHEN A SAMPLE IS READY FOR ASPIRATION. INSTRUCTIONS FOR USE FOR BOTH THE ADVIA 1650 AND THE ADVIA WORKCELL RECOMMEND PUTTING THE INSTRUMENT ON "STANDBY" MODE OR TO SHUTDOWN THE INSTRUMENT PRIOR TO WORKING ANYWHERE NEAR THE TRACKS OR SAMPLING AREAS. THE OPERATOR WAS SENT TO THE EMERGENCY ROOM AND RECEIVED SOME FIRST AID TREATMENT AND THEIR BLOOD WAS TAKEN FOR CULTURE AND TESTING AS ADVISED IN THEIR LAB PROCEDURES. BAYER HEALTHCARE LLC, DIAGNOSTICS PERSONNEL CONCLUDES THAT THIS ISSUE WAS DUE TO THE OPERATOR NOT FOLLOWING APPROPRIATE WARNINGS AND INSTRUCTIONS FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 1650 CLINICAL CHEMISTRY ANALYZER JJC JEOL, LTD ADVIA 1650 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other