BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® IMMUNOCHEMISTRY SYSTEM

    MDR report key: 2836626 · Received November 16, 2012

    Report

    Report Number
    2050012-2012-01844
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 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) 2012, A FIELD SERVICE ENGINEER (FSE) WAS ON SITE TO INVESTIGATE THE INCIDENT. THE FSE REMOVED THE WASH STATION AND CLEANED THE WASH CUP. THE FSE THEN INSPECTED THE TUBING AND NO OBSTRUCTION WAS NOTED. THE FSE REPLACED THE IN-LINER FILTER WHICH RESOLVED THE LEAK. THE FAILURE MODE OF THE EVENT WAS A WEAK IN-LINE FILTER FAILURE (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE REAGENT PROBE WASH STATION OVERFLOWED AND DID NOT DRAINING ON THE IMMAGE IMMUNOCHEMISTRY SYSTEM. THE LEAK WAS CONTAINED TO THE TOP OF THE INSTRUMENT. THE CUSTOMER INSPECTED THE WASH CUP FOR OBSTRUCTIONS; NO OBSTRUCTIONS WERE FOUND. THE CUSTOMER WORE PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES, EYE PROTECTION, AND LAB COAT AT THE TIME OF THE INCIDENT. 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 ATTRIBUTED OR ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT REVIEW THE MSDS; HOWEVER, THE FACILITY HAS AN EXPOSURE CONTROL OR RISK MANAGEMENT PLAN IN PLACE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1