BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T DIFF ANALYZER

    MDR report key: 1994176 · Received February 16, 2011

    Report

    Report Number
    1061932-2011-00079
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND FOUND AIR BUBBLES IN THE LYSE LINE AND REPLACED THE WASTE LINE PERI-PUMP TUBING. AS PER PRODUCT LABELING, BCI URGES ITS CUSTOMERS TO COMPLY WITH (B)(4) 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 THE AC*T DIFF PROBE WAS LEAKING AND BOTH BATHS WERE OVERFLOWING IN THE COULTER AC*T DIFF ANALYZER. THE CUSTOMER WAS WEARING PROPER PERSONAL PROTECTIVE EQUIPMENT (PPE). THERE WAS NO DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THERE WAS NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES, AND NO ONE SOUGHT 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