BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T 8/10 ANALYZER

    MDR report key: 3203225 · Received July 2, 2013

    Report

    Report Number
    1061932-2013-01360
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K964988
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) CONTACTED THE CUSTOMER ON (B)(4) 2013 AND RECOMMENDED THE CUSTOMER TO REPLACE THE WASTE FILTER AND PERFORM A CLEAN BATH PROCEDURE. THE CUSTOMER INDICATED THAT THE LEAK WAS RESOLVED FOLLOWING THE REPLACEMENT OF THE WASTE FILTER AND THE CLEAN BATH PROCEDURE. THE INSTRUMENT IS OPERATIONAL TO DATE. SERVICE DID NOT GO ON-SITE SINCE THE CUSTOMER RESOLVED THE ISSUE. FAILURE MODE OF THE LEAK IS RELATED TO THE WBC BATH AND WASTE FILTER. PER LABELING, BECKMAN COULTER 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, WEARING PROTECTIVE EYE WEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS INSTRUMENT OR ANY OTHER AUTOMATED LABORATORY ANALYZER. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING A FEW MLS OF FLUID LEAKED FROM AN OVERFLOW OF THE WHITE BLOOD COUNT (WBC) BATH IN THE COULTER AC*T 8/10 ANALYZER. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT AT THE TIME OF THE EVENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED. THE LABORATORY'S EXPOSURE CONTROL/RISK MANAGEMENT PLANS ARE IN PLACE. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE GENERATED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301369 COULTER AC*T 8/10 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER AC*T 8/10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1