BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF ANALYZER

    MDR report key: 3253135 · Received July 29, 2013

    Report

    Report Number
    1061932-2013-01593
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 10, 2013
    Report Date
    July 10, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON (B)(4) 2013. THE FSE OBSERVED A PROBE LEAK AND FOUND THAT DILUENT FILTERS HAD NOT BEEN CHANGED SINCE DECEMBER 2012. THE FSE REPLACED DILUENT FILTERS INSIDE THE RIGHT HAND DOOR AND 3 HYDRO BLUE FILTERS. THE FSE RAN SEVERAL STARTUP'S AND NO LEAK WAS PRESENT. WHILE ON SITE, THE FSE ALSO CLEANED THE PROBE WIPE AS PREVENTIVE MAINTENANCE. THE FSE ADVISED CUSTOMER TO INCORPORATE INTO REGULAR MAINTENANCE. FAILURE MODE OF THE LEAK WAS RELATED TO THE DILUENT FILTERS. BECKMAN INTERNAL IDENTIFIER NUMBER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT APPROXIMATELY 1 ML OF FLUID WAS LEAKING FROM THE PROBE IN THE COULTER AC*T-DIFF ANALYZER. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED BY THE CUSTOMER. THERE IS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN IN PLACE AT THE FACILITY. THE OPERATOR WAS WEARING A LABORATORY COAT AND GLOVES AT THE TIME OF THE INCIDENT. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. THERE WAS NO IMPACT TO PATIENT RESULTS. NO ERRONEOUS RESULTS WERE GENERATED AS A RESULT OF THIS EVENT. NO DEATH OR INJURY IS ATTRIBUTED TO THIS EVENT AND THERE WAS NO CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353450 COULTER® ACT DIFF ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA

    Patients

    Seq Age Sex Outcome Treatment
    1