BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T DIFF ANALYZER

    MDR report key: 2786682 · Received October 12, 2012

    Report

    Report Number
    1061932-2012-02566
    Event Type
    Malfunction
    Date Received
    October 12, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 18, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER TECHNICAL SPECIALIST (CTS) WAS INFORMED BY THE CUSTOMER OVER THE PHONE THAT THE PROBE WAS LEAKING NEAR THE END OF STARTUP AND THAT THEY HAD ALREADY REPLACED THE PROBE WIPE ASSEMBLY. THE CTS ADVISED THE CUSTOMER TO REPLACE THE DUAL DILUENT FILTERS TO RESOLVE THIS ISSUE. THE FAILURE MODE CAN BE ATTRIBUTED TO THE DILUENT FILTERS. SERVICE WAS NOT NEEDED AS THE CUSTOMER CORRECTED THE ISSUE. PER THE OPERATOR'S GUIDE / IFU: WARNINGS AND PRECAUTIONS: 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 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 THAT THE PROBE LEAKED ABOUT ½ ML OF CLEAR FLUID NEAR THE END OF THE STARTUP CYCLE ON THEIR COULTER ACT DIFF ANALYZER THAT WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING GLOVES AND A GOWN AT THE TIME THE LEAK WAS DISCOVERED. THERE WAS NO DIRECT BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THERE WAS NO DEATH, INJURY, OR AFFECT TO USER. NO ONE SOUGHT MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE GENERATED; HOWEVER, THE FAILURE MODE IDENTIFIED HAS THE POTENTIAL TO CAUSE ERRONEOUS LOW RESULTS FOR ALL PARAMETERS DUE TO SAMPLE DILUTION IF THE PROBE WERE TO LEAK INTO A PRESENTED OPEN VIAL SAMPLE OR INTO THE BATHS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1