BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T DIFF ANALYZER

    MDR report key: 2874477 · Received December 14, 2012

    Report

    Report Number
    1061932-2012-02861
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 19, 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
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2012 TO EVALUATE THIS EVENT. AS INDICATED, THE FSE CONFIRMED THE ERRONEOUS RESULTS AND THE PROBE DRIP ISSUE BY RUNNING A BEC TEST ON THE DILUENT SAMPLE. THE FSE CONFIRMED THE PROBE WAS LEAKING DILUENT UPON OPERATION OF THE INSTRUMENT AND FOUND THE VACUUM PUMP WAS NOT GENERATING ENOUGH HIGH VACUUM TO COMPLETELY EVACUATE DILUENT FROM THE PROBE DURING BACKWASH AND CAUSED DILUENT TO DRIP FROM THE PROBE INTO PRESENTED OPEN VIAL SAMPLES. THE FSE INSTALLED A NEW VACUUM PUMP, BUT WAS NOT FUNCTIONING AS EXPECTED AS IT TURNS OFF DURING INSTRUMENT CYCLE. THE INSTRUMENT WAS TEMPORARILY TAKEN OUT OF SERVICE PENDING PART REPLACEMENT. ON (B)(4) 2012, ANOTHER NEW PUMP WAS INSTALLED, BUT THE SYSTEM STILL TURNS OFF DURING THE CYCLE. HOWEVER, THE PROBE NO LONGER DRIPS WHEN THE PROBE IS BACKWASHED. THE FSE ORDERED AND WILL INSTALL A NEW MAIN BOARD. REPLACEMENT OF PART IS STILL PENDING. FAILURE MODE: VACUUM PUMP. LABELING: PER 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. BECKMAN COULTER DOES NOT CLAIM TO IDENTIFY EVERY ABNORMALITY IN SAMPLES AND SUGGESTS USING ALL AVAILABLE FLAGGING OPTIONS TO OPTIMIZE THE SENSITIVITY OF THE INSTRUMENT RESULTS. ALL FLAGGING OPTIONS INCLUDE REFERENCE RANGES (H/L), CODES, AND FLAGS. BECKMAN COULTER RECOMMENDS AVOIDING THE USE OF SINGLE MESSAGES OR OUTPUTS TO SUMMARIZE SPECIMEN RESULTS OR PATIENT CONDITIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTED THAT THE PROBE IN THE COULTER ACT DIFF ANALYZER DRIPPED A FEW DROPS INTO A FINGER STICK SAMPLE AND DILUTED IT, WHICH AFFECTED THE SAMPLE RESULTS. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER WAS WEARING GLOVES AT THE TIME THE LEAK WAS DISCOVERED. THE REVIEW OF THE PATIENT SUMMARY, SUBMITTED BY THE CUSTOMER, SHOWS ONE (1) FINGER STICK SAMPLE RUN FOUR (4) TIMES ON (B)64) 2012 WHICH HAD ERRATIC COMPLETE BLOOD COUNT (CBC) RESULTS; TWO (2) OF THE RUNS HAD INSTRUMENT GENERATED FLAGS. CORRECT RESULTS WERE NOT PROVIDED. THE PATIENT SUMMARY ALSO SHOWS A BLANK SAMPLE (DILUENT) WAS RUN ON (B)(6) 2012 BY THE DISPATCHED BEC FIELD SERVICE ENGINEER (BEC TEST) TO CONFIRM THE DRIP ISSUE AS SHOWN ON THE PATIENT DATA SUMMARY FORM. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THERE WAS NO CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    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