BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T DIFF HEMATOLOGY ANALYZER

    MDR report key: 3223193 · Received July 12, 2013

    Report

    Report Number
    1061932-2013-01452
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC CUSTOMER TECHNICAL SUPPORT (CTS) GUIDED THE CUSTOMER THROUGH FLUSHING THE VACUUM TUBING TO THE PROBE WIPE WITH BLEACH SOLUTION. CUSTOMER VERIFIED NO MORE DRIPS BY PERFORMING SHUTDOWN AND STARTUP AFTERWARDS AND HAD NO MORE DRIPS. SERVICE WAS NOT DISPATCHED FOR THIS EVENT SINCE THE CUSTOMER CORRECTED THE ISSUE BY FLUSHING THE VACUUM TUBING TO THE PROBE WIPE WITH BLEACH SOLUTION. 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 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 (BEC) REPORTING THAT APPROXIMATELY 2 MLS (A FEW DROPS) OF ISOTON LEAKED ONTO THE COUNTER TOP FROM THE COULTER AC*T DIFF HEMATOLOGY ANALYZER. THE LEAK WAS OBSERVED TO BE COMING FROM THE PROBE OR THE PROBE WIPE, RIGHT AT THE END OF STARTUP. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, A LABORATORY COAT, AND PROTECTIVE EYEWEAR AT THE TIME OF OCCURRENCE. 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. MEDICAL ATTENTION WAS NOT SOUGHT. NO ERRONEOUS PATIENT RESULTS WERE GENERATED IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324365 COULTER AC*T DIFF HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER AC*T DIFF NA

    Patients

    Seq Age Sex Outcome Treatment
    1