BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF2 HEMATOLOGY ANALYZER

    MDR report key: 3013893 · Received March 20, 2013

    Report

    Report Number
    1061932-2013-00380
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: RBC BATH AND WBC BATH. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE COULTER ACT DIFF2 HEMATOLOGY ANALYZER LEAKED APPROXIMATELY 4 ML OF CLEAR BLUE FLUID FROM THE RED BLOOD CELL (RBC) BATH. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER ALSO STATED THAT THE ANALYZER WAS GENERATING WHITE BLOOD CELL (WBC) VOTEOUTS. THE CUSTOMER WAS WEARING GLOVES AND A LAB COAT AT THE TIME OF THE OCCURRENCE, AND THERE WAS NO REPORT OF INJURY OR EXPOSURE TO WOUNDS OR MUCOUS MEMBRANES. THE CUSTOMER HAS AN EXPOSURE CONTROL PLAN IN PLACE AT THE FACILITY. NO ERRONEOUS PATIENT RESULTS WERE GENERATED AND THERE WAS NO IMPACT TO PATIENT TREATMENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER'S SITE AND INSPECTED THE ANALYZER. THE FSE FOUND THAT THE CLEANER LEAK WAS COMING FROM A CRACK IN THE BASE OF THE RBC BATH, AND REPLACED THE RBC BATH. THE FSE CHECKED THE VOLTAGE SCREEN AND FOUND THAT THE VOLTAGE READING WAS HIGH, AROUND 7.5, WHICH COULD HAVE BEEN CAUSING THE WBC VOTE OUTS. THE FSE REPLACED THE WBC BATH BECAUSE THE APERTURE WAS FAULTY. THE WBC APERTURE VOLTAGE WAS AROUND 5.0 ONCE THE REPAIR WAS COMPLETED AND THE RBC BATH DID NOT LEAK ANYMORE. THE FSE ALSO CHANGED THE VACUUM CHAMBER BECAUSE IT WAS DIRTY. THE FSE VERIFIED SERVICE ACTIVITY PERFORMED PER ESTABLISHED PROCEDURES, AND THE RESULTS MET THE PERFORMANCE SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115532 COULTER® ACT DIFF2 HEMATOLOGY ANALYZER DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER ACT DIFF2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1