BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T DIFF 2 ANALYZER

    MDR report key: 2003443 · Received March 1, 2011

    Report

    Report Number
    1061932-2011-00111
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 5, 2011
    Report Date
    February 5, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 AND DISCOVERED THAT THE WHITE BLOOD COUNT (WBC) BATH WAS OVERFLOWING. THE FSE REPLACED THE 3-WAY WASTE PINCH VALVE AND THE WASTE PUMP. THE FSE RAN NUMEROUS SAMPLES WITH NO LEAKS OBSERVED. THE FSE ALSO RAN SHUTDOWN/STARTUP AND CONTROLS, WHICH ALL PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES AND ALL RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE COULD NOT BE DETERMINED TO DATE FOR THIS EVENT. PER LABELING, BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THERE WAS FLUID LEAKING IN THE FRONT OF THE COULTER ACT DIFF 2 ANALYZER. THE SPILL WAS CLEANED UP, BY THE CUSTOMER, ACCORDING TO THE DEFINED LABORATORY PROTOCOL. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF OPERATOR EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. PATIENT TREATMENT WAS NOT AFFECTED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER AC*T DIFF 2 ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. ACT DIFF 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1