BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT DIFF ANALYZER

    MDR report key: 4243654 · Received November 11, 2014

    Report

    Report Number
    1061932-2014-02812
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 20, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 FOUND DISCONNECTED TUBING AT SOLENOID, LV8. HE RECONNECTED THE TUBING RESOLVING THE LEAK AND WHITE BLOOD CELL (WBC) VOTE OUTS (NON-NUMERIC RESULTS) FOR THE QUALITY CONTROL SAMPLES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK WHEN USING THE COULTER ACT DIFF ANALYZER. THE CUSTOMER INITIALLY REPORTED THE WHITE BLOOD CELL RESULTS FOR THE QUALITY CONTROL WERE ASSOCIATED WITH VOTE-OUTS (NON-NUMERIC RESULTS) AND ISSUES WITH THE RINSE BLOCK. THE CUSTOMER THEN IDENTIFIED A LEAK OF APPROXIMATELY 2-3 DROPS FROM THE PROBE AREA OF THE ANALYZER. PATIENT SAMPLES WERE NOT TESTED, AND THEREFORE NOT AFFECTED. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE ANALYZER. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT OF LAB COAT AND GLOVES WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR CUTS. THERE WAS NO DEATH, INJURY OR AFFECT TO USER OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727163 COULTER ACT DIFF ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1