BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T DIFF ANALYZER

    MDR report key: 1964445 · Received January 19, 2011

    Report

    Report Number
    1061932-2011-00035
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 21, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010064
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INITIALLY CONTACTED THE BCI CALL CENTER TO REPORT THE LEAK AND WAS INSTRUCTED TO MAINLY DRAIN THE BATHS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4)2010 FOR THIS EVENT. THE FSE PERFORMED A SHUTDOWN, STARTUP ON ALL VALVES AND PUMPS, BLEACHED APERTURES, PRIMED THE INSTRUMENT, AND RAN PATIENT SAMPLES AND CONTROLS. PER THE FSE AFTER BLEACHING THE SYSTEM, NO ISSUES WERE OBSERVED. ROOT CAUSE IS UNKNOWN FOR THIS EVENT. BCI URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT 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 THE WHITE BLOOD COUNT (WBC) AND THE RED BLOOD COUNT (RBC) BATHS WERE OVERFLOWING ON THE COULTER ACT DIFF ANALYZER. THE CONTROL MATERIAL AND THE BATH CONTENTS SPILLED ON THE INSTRUMENT. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS (EYES, MOUTH, AND NOSE). NO ONE SOUGHT OUT MEDICAL ATTENTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1