BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF HEMATOLOGY ANALYZER

    MDR report key: 3041623 · Received April 8, 2013

    Report

    Report Number
    1061932-2013-00549
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K964988
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER THAT THE COULTER ACT DIFF HEMATOLOGY ANALYZER LEAKED A FEW DROPS OF LIQUID FROM THE PROBE FOLLOWING THE INSTRUMENT STARTUP. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING GLOVES AND A LAB COAT AT THE TIME OF THE OCCURRENCE. THERE WAS NO REPORT OF INJURY OR EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES, AND MEDICAL ATTENTION WAS NOT SOUGHT. THE CUSTOMER DID NOT REVIEW THE MATERIAL SAFETY DATA SHEET (MSDS), BUT HAS AN EXPOSURE CONTROL PLAN AT THE FACILITY. NO ERRONEOUS PATIENT RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) OBSERVED THAT THE LEAK WAS COMING FROM A CLOGGED WASTE LINE. THE FSE CLEANED THE WASTE LINE WITH BLEACH, WHICH REMOVED CLOG AND RESOLVED THE LEAK. THE FSE REPLACED THE DILUENT RESERVOIR FILTERS AS PREVENTATIVE MAINTENANCE. THE REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143788 COULTER® ACT DIFF HEMATOLOGY ANALYZER DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER ACT DIFF 8/10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1