BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF HEMATOLOGY ANALYZER

    MDR report key: 2880669 · Received December 20, 2012

    Report

    Report Number
    1061932-2012-02838
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K964988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER WAS INITIALLY DISPATCHED TO THE SITE, HOWEVER, THE CUSTOMER SUBSEQUENTLY CANCELED THE SERVICE REQUEST. THE CUSTOMER CALLED TO ADVISE THAT THEY REMOVED AND REPLACED DILUENT FILTERS WHICH CORRECTED THE LEAK. NO FURTHER LEAKING WAS NOTED AND NO FURTHER INFORMATION WAS PROVIDED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER A LEAK INSIDE THE COULTER ACT DIFF HEMATOLOGY ANALYZER. THE VOLUME OF THE LEAK WAS A FEW DROPS; THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THERE ARE NO REPORTS OF ANY INJURIES OR EXPOSURES TO ANY LABORATORY PERSONNEL. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AT THE TIME OF THE EVENT. THERE WERE NO ERRONEOUS RESULTS GENERATED AND ACCORDINGLY, THERE WERE NO CHANGES TO ANY PATIENT CARE OR TREATMENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® ACT DIFF HEMATOLOGY ANALYZER DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1