BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT DIFF 2 ANALYZER

    MDR report key: 1748613 · Received July 7, 2010

    Report

    Report Number
    1061932-2010-00059
    Event Type
    Malfunction
    Date Received
    July 7, 2010
    Date of Event
    June 7, 2010
    Report Date
    July 7, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED FOR THIS EVENT. PER PRODUCT LABELING, BECKMAN COULTER, INC. URGES IT 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 A SMALL AMOUNT OF CONTROL MATERIAL ON THE TOP OF THE TUBE SPILLED ONTO THE OPERATOR'S HAND. THE OPERATOR WAS NOT WEARING PPE. THE SMALL AMOUNT OF CONTROL MATERIAL WAS WASHED OFF AT THE SINK AND THE OPERATOR WAS ADVISED TO SEEK MEDICAL ATTENTION, BUT DID NOT. THERE WAS NO SERIOUS INJURY REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER ACT DIFF 2 ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. ACT DIFF 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1