BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC *T DIFF 2 ANALYZER

    MDR report key: 2993589 · Received March 7, 2013

    Report

    Report Number
    1061932-2013-00310
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE INVESTIGATED THE EVENT AND CONFIRMED A DILUENT LEAK FROM THE PROBE RINSE BLOCK. THE FSE INDICATED THAT SOLENOID VALVE # 10 WAS NOT SWITCHING. THE SOLENOID WAS REPLACED, RESOLVING THE LEAK. THE FSE REVIEWED QC DATA AND DISCOVERED HIGH, OUT OF RANGE QC VALUES FOR RED BLOOD COUNT (RBC). THE FSE INDICATED THAT THIS WAS ALSO CAUSED BY THE SOLENOID VALE #10 NOT SWITCHING PROPERLY. THE FSE ALSO INVESTIGATED THE HIGH PLATELET BACKGROUND RESULTS GENERATED ON STARTUP. PER THE FSE, THE REAGENT PACK MAY HAVE BEEN FROZEN DURING THE SHIPPING. THE REAGENT PACK WAS MIXED AND THEN THE STARTUP WAS REPEATED AND PASSED SUCCESSFULLY. FAILURE MODE OF THE LEAK WAS RELATED TO THE SOLENOID #10 NOT SWITCHING PROPERLY. THE PLATELET BACKGROUND FAILED AS A RESULT OF THE REAGENT PACK BEING FROZEN DURING THE SHIPPING. HOWEVER, THE PLATELET FAILURES IN THIS EVENT WERE NOT RELATED TO THE LEAK. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, (BEC) TO REPORT GETTING HIGH PLATELET BACKGROUND RESULTS ON STARTUP AND THEY ALSO REPORTED A LEAK OF FLUID COMING FROM UNDER THE COULTER ACT DIFF 2 ANALYZER. THE VOLUME WAS REPORTED AS ABOUT 30 ML AND THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE MATERIAL SAFETY DATA SHEET MSDS WAS NOT REVIEWED. THERE IS AN EXPOSURE CONTROL PLAN AT THE FACILITY. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), CONSISTING OF GLOVES AND A LABORATORY COAT. NO ONE WAS SPLASHED, SPRAYED OR INJURED. THERE WAS NO CONTACT TO OPEN OR BROKEN SKIN OR MUCOUS MEMBRANES. NO ONE SOUGHT MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION TO THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98253 COULTER® AC *T DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA

    Patients

    Seq Age Sex Outcome Treatment
    1