BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF 12¿ ANALYZER

    MDR report key: 2902733 · Received January 9, 2013

    Report

    Report Number
    1061932-2013-00024
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER RESOLVED THE ISSUE THROUGH TROUBLESHOOTING VIA THE TELEPHONE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY ONE HALF CUP OF FLUID OVERFLOWED FROM THE WHITE BLOOD CELL (WBC) BATH FROM UNDERNEATH THE INSTRUMENT WHILE ANALYZING TEN PATIENT SAMPLES INVOLVING THE COULTER ACT DIFF 12 ANALYZER. THE CUSTOMER HAD ON PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. THE CUSTOMER QUESTIONED THE INITIAL PATIENT RESULTS. BECKMAN COULTER CUSTOMER TECHNICAL SUPPORT (CTS) ADVISED THE CUSTOMER TO DRAIN THE WBC WITH BLEACH AND PERFORMED SYSTEM STARTUP. THE BATH DRAINED NORMALLY, AND THE CUSTOMER PERFORMED SYSTEM STARTUP WHICH PASSED WITHIN SPECIFICATIONS. THE CUSTOMER CONFIRMED NO FURTHER LEAKS WERE PRESENT. THE INITIAL PATIENT RESULTS WERE NOT RELEASED FROM THE LABORATORY. THERE WAS NO PATIENT IMPACT. IT IS UNKNOWN IF THE INITIAL RESULTS WERE ERRONEOUS. ALL TEN PATIENT SAMPLES WERE REANALYZED. THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11024 COULTER® ACT DIFF 12¿ ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1