BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE IMMUNOCHEMISTRY SYSTEM

    MDR report key: 2495799 · Received March 19, 2012

    Report

    Report Number
    2050012-2012-00789
    Event Type
    Malfunction
    Date Received
    March 19, 2012
    Date of Event
    February 28, 2012
    Report Date
    February 28, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJY
    PMA / PMN Number
    K962294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(4) 2012, CUSTOMER REPORTED THAT THE IMMAGE 800 INSTRUMENT DISPLAYED "VACUUM OUT OF RANGE" ERRORS. CUSTOMER ALSO STATED THAT THE SAMPLE AND REAGENT PROBE WASH STATIONS WERE NOT DRAINING, AND WERE OVERFLOWING NO INJURIES WERE REPORTED AND NO ERRONEOUS PATIENT RESULTS WERE GENERATED. FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND THE FLUIDICS. FSE ACTIVATED THE VALVES AND THE WASH CUPS DRAINED. FSE COULD NOT DUPLICATE THE EVENT AND REBUILT THE VACUUM PUMP BASED UPON THE CUSTOMER'S REPORT OF THE VACUUM ERRORS. FSE ALSO LEARNED FROM THE CUSTOMER THAT UPON ENCOUNTERING THE VACUUM ERRORS, THE CUSTOMER PREMATURELY SHUTDOWN THE SYSTEM. FSE ADVISED THE CUSTOMER THAT THE PREMATURE SHUTDOWN DID NOT ALLOW THE SYSTEM TO FULLY CYCLE AND THEREFORE CAUSED THE FLUID BACK-UP. FSE NOTED THAT THE OVERFLOW WAS CAUSED BY USER ERROR. NO FURTHER ISSUES WERE REPORTED AND THE REPAIR WAS VERIFIED THROUGH ESTABLISHED PROCEDURES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1