BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM

    MDR report key: 2828157 · Received November 12, 2012

    Report

    Report Number
    2050012-2012-01821
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JQX
    PMA / PMN Number
    K962294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 20128, A FIELD SERVICE ENGINEER (FSE) WAS ON SITE AND FOUND A LOOSE CONNECTION BETWEEN THE WASH BUFFER SUPPLY AND THE SYRINGE SELECTOR VALVE. THE FSE SECURED THE FITTING INTERNAL PROBE WASH ASSEMBLY. THE FAILURE MODE OF LEAK WAS THE LOOSE FITTING INTERNAL PROVE WASH ASSEMBLY. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN UNCONTAINED FLUID LEAK UNDERNEATH THE IMMAGE 800 IMMUNOCHEMISTRY SYSTEMS, WHICH LEAKED ONTO THE COUNTER TOP. PER CUSTOMER THIS IS A NEW INSTRUMENT AND THEY HAVE NOT RUN PATIENT SAMPLES ONLY QUALITY CONTROLS ON IT. 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 INJURY OR EXPOSURE (SPRAYED OR SPLASHED) TO MUCOUS MEMBRANES OR OPEN WOUNDS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1