BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA 1650

    MDR report key: 599828 · Received May 6, 2005

    Report

    Report Number
    2432235-2005-00007
    Event Type
    Other
    Date Received
    May 6, 2005
    Date of Event
    April 6, 2005
    Report Date
    April 7, 2005
    Manufacturer
    JEOL, LTD.
    Product Code
    JJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2005 A HEALTHCARE PROFESSIONAL AT A MEDICAL CENTER REPORTED THAT AN OPERTOR OF THE ADVIA 1650 CHEMISTRY ANALYZER SUFFERED A PUNCTURE INJURY ON ONE HAND BY THE INSTRUMENTS' SAMPLE DILUTION PROBE (DPP). THE OPERATOR WAS SENT TO THE E.R. AND RECEIVED A TETANUS SHOT AND WAS TESTED FOR HIV. INSTRUCTIONS FOR USE FOR THE INSTRUMENT INDICATE THAT IN ORDER TO AVOID A RISK OF INJURY AND TO PREVENT DAMAGE TO THE INSTRUMENT ALL THE ANALYZER COVERS SHOULD BE IN PLACE AND TO ENSURE THAT PROBES AND MIXERS ARE FREE TO MOVE WIHOUT OBSTRUCTION PRIOR TO STARTING UP THE SYSTEM. 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 JJE JEOL, LTD. ADVIA 1650 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other