BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF ANALYZER

    MDR report key: 2823382 · Received November 7, 2012

    Report

    Report Number
    1061932-2012-02648
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER WENT ON-SITE A DAY AFTER THE EVENT AND CONFIRMED THE LEAK. FSE REPLACED THE ASPIRATION PROBE AND THE PROBE WIPE WHICH RESOLVED THE LEAK. THE FATAL ERROR 7 WAS CAUSED BY THE FACT THAT THE PROBE SENSOR GOT CAUGHT ON THE SAMPLE TUBING AND POPPED OFF. FSE REPLACED THE PROBE SENSOR AND ADJUSTED THE SAMPLE LINE WHICH RESOLVED THE ERROR MESSAGE. PREVENTATIVE MAINTENANCE WAS PERFORMED TO OPTIMIZE THE ANALYZER. THE CAUSE OF THE LEAK IS RELATED TO THE ASPIRATION PROBE AND THE PROBE WIPE WHICH NEEDED TO BE REPLACED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT THEIR COULTER ACT DIFF ANALYZER LEAKED 10 DROPS OF CLEAR FLUID DURING STARTUP. THE CUSTOMER DID NOT KNOW THE SOURCE OF THE LEAK. THE LEAK WAS NOT CONTAINED AND THE INSTRUMENT RECOVERED A FATAL ERROR 7 (WHICH ALERTED THE OPERATOR TO AN INSTRUMENT PROBLEM). NO ERRONEOUS RESULTS WERE GENERATED. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LAB COAT AT THE TIME OF THE EVENT. NO INJURY OR EXPOSURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® ACT DIFF ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. ACT DIFF NA

    Patients

    Seq Age Sex Outcome Treatment
    1