BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF ANALYZER

    MDR report key: 2817807 · Received November 2, 2012

    Report

    Report Number
    1061932-2012-02638
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 12, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON (B)(4) 2012. THE FSE INSPECTED THE INSTRUMENT AND OBSERVED LEAK AND ORDERED PARTS FOR A RETURN VISIT. THE FSE RE-VISITED THE CUSTOMER SITE AND REPLACED FAULTY RINSE BLOCK THAT WAS LEAKING, RESOLVING THE ISSUE. THE FSE ALSO REPLACED SOLENOID VALVE (VL8), THE PROBE, AN AIR FILTER, AND AN O-RING. PER 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. THE CAUSE OF THE LEAK WAS FAULTY RINSE BLOCK. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) AND STATED THEY WERE TRYING TO RUN CONTROLS WHEN THE PROBE STARTED DRIPPING ON THEIR COULTER ACT DIFF ANALYZER. THEY NOTICED A DROP OF BLOOD DRIPPING. THE CUSTOMER THEN RAN BLEACH TO REMOVE ANYTHING THAT MIGHT BE CLOGGED ON THE PROBE; THE BLEACH ALSO DRIPPED, 1 TO 2 DROPS. THERE WAS NO BIOHAZARD EXPOSURE TO ANYONE AND NO CONTACT TO OPEN OR BROKEN SKIN OR MUCOUS MEMBRANES SUCH AS THE EYES, NOSE, OR MOUTH. THE LAB TECH WAS WEARING A LAB COAT AND GLOVES; NO SHIELDS WERE USED. THE MSDS DID NOT NEED TO BE REVIEWED AND NO ONE HAD TO SEEK MEDICAL ATTENTION. THERE IS A RISK MANAGEMENT/EXPOSURE CONTROL PLAN IN PLACE. THERE WERE NO PATIENT RESULTS AFFECTED AS PATIENT SAMPLES HAD NOT BEEN RUN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1