BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM

    MDR report key: 2555610 · Received May 2, 2012

    Report

    Report Number
    2050012-2012-00057
    Event Type
    Malfunction
    Date Received
    May 2, 2012
    Date of Event
    April 5, 2012
    Report Date
    April 6, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K962294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER STATED THAT THE SAMPLE PROBE WASH STATION IS NOT DRAINING AND FLUID (WASH SOLUTION) OVERFLOWED ONTO THE TOP OF THE IMMAGE 800 IMMUNOCHEMISTRY SYSTEMS. THE LEAK WAS CONTAINED TO A SMALL AREA AROUND THE OPENING OF THE WASH STATION. CUSTOMER TECHNICAL SUPPORT (CTS) RECOMMENDED THE USE OF PERSONAL PROTECTIVE EQUIPMENT BEFORE TROUBLESHOOTING. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT, EYE PROTECTION, AND GLOVES. THE CUSTOMER DID NOT COME IN CONTACT WITH THE FLUID AND DID NOT SEEK MEDICAL ATTENTION. NO EXPOSURE (SPRAYED OR SPLASHED) TO MUCOUS MEMBRANES OR OPEN WOUNDS WERE REPORTED. NO DEATH, INJURY OR CHANGES TO PATIENT TREATMENT OR RESULTS ARE ASSOCIATED WITH THIS EVENT. THE CUSTOMER ENTERED AND EXITED THE DIAGNOSTIC MODE; HOWEVER, IT DID NOT RESOLVE THE PROBLEM. THE CUSTOMER ALSO POWERED DOWN AND REBOOTED THE INSTRUMENT. SERVICE REQUEST WAS GENERATED TO ADDRESS THE EVENT AND THE CUSTOMER WAS ADVISED NOT TO OPERATE THE INSTRUMENT UNTIL SERVICE ARRIVES. FIELD SERVICE ENGINEER (FSE) REPLACED THE SCD FILTER ON SAMPLE VACUUM WASH STATION AND REPLACED THE VACUUM PUMP KIT REPAIR. FSE RAN CONTROLS. THE CAUSE OF THE EVENT APPEARS TO BE FILTER RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM NEPHELOMETER, FOR CLINICAL USE JJE BECKMAN COULTER, INC. IMMAGE 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1