BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC-T DIFF 2 ANALYZER

    MDR report key: 2148391 · Received June 10, 2011

    Report

    Report Number
    1061932-2011-00572
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    October 17, 2008
    Report Date
    October 17, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER PRODUCT LABELING: BECKMAN COULTER, INC. URGES 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. ON (B)(4) 2008, THE FIELD SERVICE ENGINEER INSTALLED A NEW WASTE SENSOR ASSEMBLY AND VERIFIED THE INSTRUMENT. THE ROOT CAUSE IS ASSOCIATED WITH THE DEFECTIVE WASTE SENSOR ASSEMBLY. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A POTENTIAL BIOHAZARD EXPOSURE EVENT ON (B)(6) 2008 WHEN USING THE COULTER AC-T DIFF 2 ANALYZER. THE WASTE SENSOR FAILED AND THE WASTE CONTAINER OVERFLOWED ONTO THE FLOOR. OPERATOR WAS WEARING APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN LESIONS. OPERATOR DID NOT SEE MEDICAL ATTENTION. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO OPERATOR SAFETY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER AC-T DIFF 2 ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA