BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT¿ 5DIFF AUTOLOADER (AL)

    MDR report key: 2855181 · Received December 3, 2012

    Report

    Report Number
    1061932-2012-02813
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K030291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) STATED THE FLUID THE CUSTOMER OBSERVED WAS THE NORMAL AMOUNT OF FLUID FROM THE NEEDLE PULLING OUT OF THE TUBE STOPPER. UNRELATED TO THE PROBE FLUID LEAK, THE FSE INSTALLED A NEW COUNT SYRINGE AND THE WHITE BLOOD CELL (WBC)/BASO BATH DUE TO A VACUUM LEAK AROUND THE COUNT HEAD, RESOLVING THE WBC VOTEOUT ISSUE. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE UNIT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY TWO DROPS OF CLEAR DILUENT LEAKED FROM THE PROBE AND ONTO THE TOP OF EACH SAMPLE VIAL AT THE END OF TESTING INVOLVING THE COULTER ACT 5DIFF AUTOLOADER (AL). THE CUSTOMER ALSO OBTAINED WHITE BLOOD CELL (WBC) VOTEOUTS AND STATED THE RINSE BATH WAS DIRTY. THE CUSTOMER PERFORMED AN EXTENDED CLEAN BUT IT WAS UNSUCCESSFUL. THE CUSTOMER HAD ON GLOVES DURING THE EVENT AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. PATIENT RESULTS WERE NOT IMPACTED. THE CUSTOMER HAS AN EXPOSURE CONTROL PLAN AT THE FACILITY. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® ACT¿ 5DIFF AUTOLOADER (AL) COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1