BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3962267 · Received July 28, 2014

    Report

    Report Number
    1061932-2014-01757
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 29, 2014
    Report Date
    June 29, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER AND CONFIRMED THE LEAK FROM THE WBC (WHITE BLOOD CELL) APERTURE. THE BATH ASSEMBLY WAS DIFFICULT TO SEAT OVER THE APERTURES, AND THE BATH WAS REPLACED. THE LEAK AND THE HEMOGLOBIN INCOMPLETE RESULTS (NON-NUMERIC, VOTE OUTS) WERE RESOLVED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A LEAK WHEN USING THE COULTER LH 780 HEMATOLOGY ANALYZER. THE LEAK WAS ABOUT 2 ML OF FLUID FROM THE ANALYZER. THE LEAK WAS NOT CONTAINED. THE INSTRUMENT ALSO GENERATED HEMOGLOBIN INCOMPLETE RESULTS (NON-NUMERIC, VOTE OUTS) IN CONNECTION WITH THE LEAK. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE ANALYZER. THE OPERATOR WAS WEARING A LAB COAT, EYEGLASSES, AND GLOVES AT THE TIME OF THE INCIDENT. THERE WAS NO REPORT OF BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THERE WAS NO REPORT OF ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439606 COULTER LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1