BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 3672609 · Received March 11, 2014

    Report

    Report Number
    1061932-2014-00554
    Event Type
    Malfunction
    Date Received
    March 11, 2014
    Date of Event
    February 18, 2014
    Report Date
    February 18, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND CLEANED THE HEMOGLOBIN CUVETTE AND PERFORMED CUVETTE/LAMP/DETECTOR ALIGNMENT TO ADDRESS THE HEMOGLOBIN SHIFT ERRORS. THE FSE FOUND A WHITE FILM BUILDUP IN THE HEMOGLOBIN CUVETTE/CHAMBER. FOR THE PROBE LEAK, THE FSE FOUND THE PROBE WASTE CHAMBER BACKED UP DUE TO A VACUUM ERROR, TURNING OFF THE PNEUMATICS AND STOPPING THE INSTRUMENT. THIS CAUSED THE PROBE AND RINSE BLOCK TO VENT AND DRIP. HE TURNED ON THE PNEUMATICS, FLUSHED THE WASTE CHAMBERS, AND PRIMED INSTRUMENT TO CORRECT THE ISSUE. EVALUATION OF PRODUCT LABELING: UNICEL DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM INSTRUCTIONS FOR USE, (B)(4): 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK WHEN USING THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE INSTRUMENT WAS GENERATING HEMOGLOBIN BLANK SHIFT ERRORS AND THE SAMPLE PROBE WAS LEAKING APPROXIMATELY LESS THAN 1 ML OF BLOODY FLUID. THE LEAK WAS NOT CONTAINED. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT OF GLOVES AND LAB COAT. THERE WERE NO REPORTS OF EXPOSURE TO MUCOUS MEMBRANES OR CUTS. THE HEMOGLOBIN BLANK SHIFT ERRORS OCCURRED ON PATIENT SAMPLES. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB. THERE WAS NO DEATH, INJURY, OR AFFECT TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144673 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1