BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T DIFF 2 ANALYZER

    MDR report key: 2855189 · Received December 3, 2012

    Report

    Report Number
    1061932-2012-02713
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 6, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) TROUBLESHOT THE ISSUE WITH THE CUSTOMER OVER THE PHONE. THE CUSTOMER STATED THAT THERE WAS A LEAK AT THE PROBE OF THE INSTRUMENT. THE FSE INSTRUCTED THE CUSTOMER TO CLEAN THE PROBE WIPE. AFTER CLEANING THE PROBE WIPE THE INSTRUMENT WAS RUNNING WITHOUT ANY LEAKS. FAILURE MODE: THE CAUSE OF THE LEAK WAS THE PROBE WIPE. PER PRODUCT 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 INC. (BEC) REPORTING A LEAK AT THE PROBE OF THE COULTER AC*T DIFF 2 ANALYZER. THE VOLUME OF THE LEAK WAS ABOUT 2 ML AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PPE CONSISTING OF GLOVES AND A LAB COAT AT THE TIME OF THE OCCURRENCE. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION TO THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER AC*T DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER INC. ACT DIFF 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1