BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF HEMATOLOGY ANALYZER

    MDR report key: 3033842 · Received April 3, 2013

    Report

    Report Number
    1061932-2013-00547
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 APPROXIMATELY A DROP OF FLUID AT THE PROBE. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER ALSO REPORTED THAT THE INSTRUMENT GENERATED VACUUM ERROR MESSAGES WHEN THE LEAK WAS NOTICED. 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) FOUND THAT THE VACUUM PUMP WAS NOT OPERATING PROPERLY AND THE VACUUM ON THE INSTRUMENT WAS LOW. THE FSE REPLACED THE VACUUM PUMP. THE INSTRUMENT RECOVERED VACUUM AND RAN WITHOUT ANY LEAKS OR ERRORS. THE FSE VERIFIED THE REPAIRS PER ESTABLISHED PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136060 COULTER® ACT DIFF HEMATOLOGY ANALYZER DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER ACT DIFF 16 PARAMETERS NA

    Patients

    Seq Age Sex Outcome Treatment
    1