BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 3003000 · Received March 13, 2013

    Report

    Report Number
    1061932-2013-00397
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. THE FSE HAD OBSERVED THAT THE INSTRUMENT WAS SPLATTERING BLOOD ONTO THE CASSETTES AND THE SPECIMEN TRANSPORT MODULE (STM). THE FSE ADJUSTED THE PROBE WASH COLLAR UNTIL IT WAS FLUSH WITH THE OPENING IN THE PROBE AND CLEANED THE CASSETTES AND THE STM. THE FSE RAN SHUTDOWN AND DAILY CHECKS. THE INSTRUMENT RAN WITHOUT ANY ISSUES. 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. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING THAT THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM SPLATTERED BLOOD IN MULTIPLE SPOTS THAT WERE GETTING ON THE CASSETTE LABELS. THERE WAS NO SPILL JUST SPLATTER. THE INSTRUMENT DID NOT GENERATE ANY ERROR MESSAGES OR FLAGS AS A RESULT OF THIS EVENT. THE CUSTOMER WAS WEARING PROPER PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LABORATORY COAT AND GLOVES AT THE TIME OF OCCURRENCE. THERE WAS NO CONTACT TO OPEN OR BROKEN SKIN OR MUCOUS MEMBRANES. NO ONE SOUGHT MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105595 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER DXH 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1