BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T DIFF HEMATOLOGY ANALYZER

    MDR report key: 3230612 · Received July 16, 2013

    Report

    Report Number
    1061932-2013-01507
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT AND OBSERVED THAT THE INSTRUMENT HAS A DILUENT LEAK. THE FSE REPLACED THE DILUENT FILTERS AND PINCH VALVE AND TUBING AT LV10. LV10 IS THE PATHWAY FOR DILUENT FROM THE DILUENT PUMP TO THE PROBE WASH WHEN ON THE ON POSITION AND THE PATHWAY FOR DILUENT FROM THE DILUENT PUMP TO THE DILUENT RESERVOIR WHILE ON THE OFF POSITION. NO FURTHER EVIDENCE OF LEAKING WAS OBSERVED AFTER SERVICE ACTIVITIES WERE PERFORMED. FAILURE MODE: THE CAUSE OF THE LEAK WAS VL10 AND THE DILUENT FILTERS. 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 THE PROBE WAS DRIPPING INTERMITTENTLY AT THE END OF THE STARTUP CYCLE AND WHILE RUNNING CONTROLS ON THE COULTER AC*T DIFFERENTIAL HEMATOLOGY ANALYZER. THE LEAK WAS APPROXIMATELY 1 ML AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE INSTRUMENT DID NOT GENERATE ANY ERROR MESSAGES OR FLAGS AS A RESULT OF THIS EVENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AT THE TIME OF OCCURRENCE. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS 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. THE FOLLOWING MDRS DOCUMENT OTHER OCCURRENCES ON THIS ISSUE AT THIS CUSTOMER SITE: 1061932-2013-00676, 1061932-2013-01008, 1061932-2013-01243.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328070 COULTER AC*T DIFF HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER AC*T DIFF NA

    Patients

    Seq Age Sex Outcome Treatment
    1