BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM

    MDR report key: 2644162 · Received July 7, 2012

    Report

    Report Number
    2050012-2012-01553
    Event Type
    Malfunction
    Date Received
    July 7, 2012
    Date of Event
    June 12, 2012
    Report Date
    June 12, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K962294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON THE DAY OF THE EVENT A FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND INVESTIGATED THE EVENT. THE FSE DETERMINED THE LEAK WAS A WASH SOLUTION AND ORIGINATED FROM A LOOSE FITTING ON THE PROBE INTERNAL WASH STATION. THE FSE SECURED THE LOOSE FITTING WHICH RESOLVED THE ISSUE. SERVICE ACTIVITY PERFORMED IS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE CAUSE OF THE EVENT WAS LOOSE FITTING. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A FLUID LEAK FROM THE SAMPLE PROBE ON THE IMMAGE 800 IMMUNOCHEMISTRY SYSTEMS. THE LEAK WAS CONTAINED TO A SMALL AREA AROUND THE OPENING OF THE WASH STATION. THE CUSTOMER STATED THE FLUID LEAKED DOWN INTO THE SAMPLE CAROUSEL. THE LEAK WAS CONTAINED WITHIN A MALL AREA WITHIN THE SAMPLE WHEEL WELL. PER CUSTOMER NO ERRONEOUS RESULTS WERE GENERATED OR REPORTED OUT OF THE LABORATORY. 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.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1