BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC T 5DIFF CP ANALYZER

    MDR report key: 2983600 · Received February 28, 2013

    Report

    Report Number
    1061932-2013-00270
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K003677
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE FOUND THE REAGENT SYRINGE WAS CRACKED AND LEAKING LYSE REAGENT. THE LYSE REAGENT LEAKED INTO THE DRIP TRAY UNDER THE SYRINGES AND EVENTUALLY TO THE BOTTOM OF THE INSTRUMENT. THE REAGENT SYRINGE MAY CONTAIN LYSE WHILE IN OPERATION AND CLEANER WHILE IN SHUTDOWN. THE FSE REPLACED THE REAGENT SYRINGE AND RESOLVED THE LEAK. PER LABELING, BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. FAILURE MODE OF THIS EVENT WAS REAGENT SYRINGE CRACKED AND LEAKING LYSE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) A LEAK OF CLEAR SOAPY FLUID UNDERNEATH THE COULTER AC T 5DIFF CP ANALYZER. THE VOLUME OF THE LEAK WAS REPORTED BY THE CUSTOMER AS 2 TO 5 ML. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS REVIEWED. THERE IS AN EXPOSURE CONTROL PLAN AT THE FACILITY. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), CONSISTING OF GLOVES AND A LABORATORY COAT. NO ONE WAS SPLASHED, SPRAYED OR INJURED. THERE WAS NO CONTACT TO OPEN OR BROKEN SKIN OR MUCOUS MEMBRANES. NO ONE SOUGHT MEDICAL ATTENTION. NO PATIENT RESULTS WERE AFFECTED. THERE WAS NO DEATH, INJURY OR AFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85659 COULTER® AC T 5DIFF CP ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER ACT 5DIFF CP NA

    Patients

    Seq Age Sex Outcome Treatment
    1