BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF2 HEMATOLOGY ANALYZER

    MDR report key: 2731458 · Received September 6, 2012

    Report

    Report Number
    1061932-2012-02407
    Event Type
    Malfunction
    Date Received
    September 6, 2012
    Date of Event
    August 15, 2012
    Report Date
    August 15, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE PROBE ON COULTER ACT DIFF2 HEMATOLOGY ANALYZER HAD BEEN LEAKING AFTER EACH RUN LEAVING A BIG DROP OF REAGENT UNDER THE PROBE. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT AND THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES AND A LAB COAT. THERE WAS NO IMPACT TO PATIENT RESULTS, AND NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THERE WAS NO DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT ASSOCIATED TO THIS EVENT AND THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. MSDS WAS REVIEWED, AND THERE IS AN EXPOSURE CONTROL OR RISK MANAGEMENT PLAN IN PLACE AT THE FACILITY. A BECKMAN COULTER FIELD SERVICE ENGINEER FOUND DILUENT WAS INTERMITTENTLY LEAKING FROM RINSE BLOCK AND REPLACED VALVES AND PROBE. THE ENGINEER ALSO REPLACED LAMP TO ADDRESS LOW LAMP VOLTAGE. THE SERVICE ACTIVITY PERFORMED WAS VERIFIED PER ESTABLISHED PROCEDURES, AND THE RESULTS MET THE PUBLISHED PERFORMANCE SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1