BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF 12¿ ANALYZER

    MDR report key: 2565078 · Received May 8, 2012

    Report

    Report Number
    1061932-2012-01519
    Event Type
    Malfunction
    Date Received
    May 8, 2012
    Date of Event
    April 16, 2012
    Report Date
    April 17, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) DISCOVERED CLENZ SOLUTION OVERFLOWED FROM THE RED BLOOD CELL (RBC) BATH WHEN THE CUSTOMER PRIMED THE CLENZ REAGENT DUE TO A FALSE LOW ERROR MESSAGE. THE FSE REPLACED THE INLINE FLUID DETECTOR AND RESOLVED THE ISSUE. THE UNIT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. THE CUSTOMER HAS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN AT THE FACILITY. BECKMAN COULTER, INC. (BEC) INTERNAL IDENTIFIER FOR THIS REPORT IS 1061932-2012-01519.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FEW MILLILITERS OF CLENZ SOLUTION OVERFLOWED WITH LOW ALARM ALERT INVOLVING COULTER ACT DIFF 12 ANALYZER. THE CUSTOMER NOTED SUFFICIENT CLENZ SOLUTION WAS IN THE BOTTLE. THE CUSTOMER INDICATED THE RED BLOOD CELL (RBC) BATH OVERFLOWED WITH THE CLENZ SOLUTION, AND THE WHITE BLOOD CELL (WBC) BATH DID NOT FILL WITH THE SOLUTION. THE CUSTOMER HAD ON PERSONAL PROTECTIVE EQUIPMENT (PPE): GLOVES AND A LABORATORY COAT DURING THE INCIDENT. PATIENT RESULTS WERE NOT IMPACTED. THE CUSTOMER DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO EXPOSURE TO OPEN LESIONS OR MUCUS MEMBRANES. THERE WAS NO REPORT OF INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS INCIDENT. THE FIELD SERVICE ENGINEER (FSE) ASSESSED THE UNIT AT THE FACILITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1