BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT DIFF ANALYZER

    MDR report key: 3894424 · Received June 25, 2014

    Report

    Report Number
    1061932-2014-01466
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, THE BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER AND CONFIRMED THE WBC (WHITE BLOOD CELL) BATH WAS NOT DRAINING AND REPLACED PINCH VALVES LV14 AND LV15 RESOLVING THE WBC BATH OVERFLOW. QUALITY CONTROL SAMPLES AND PATIENT SAMPLES WERE RERUN FOR VERIFICATION POST REPAIR. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK WHEN USING THE COULTER ACT DIFF ANALYZER. THE WBC (WHITE BLOOD CELL) BATH OF THE ANALYZER WAS OVERFLOWING. THE VOLUME OF THE LEAK WAS LESS THAN 25 ML; THE LEAK WAS NOT CONTAINED. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT OF LAB COAT, GOGGLES, AND GLOVES WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR CUTS. THERE WAS NO REPORT OF ERRONEOUS TEST RESULTS REPORTED OUT OF THE LABORATORY WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO USER OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370846 COULTER ACT DIFF ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1