BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T DIFF 2 ANALYZER

    MDR report key: 3257761 · Received July 31, 2013

    Report

    Report Number
    1061932-2013-01632
    Event Type
    Malfunction
    Date Received
    July 31, 2013
    Date of Event
    July 9, 2013
    Report Date
    July 9, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE FOR THIS EVENT. THE FSE CONFIRMED A LEAK DUE TO THE WHITE BLOOD CELL (WBC) AND RED BLOOD CELL (RBC) BATH NOT PROPERLY DRAINING. THE FSE PROCEEDED TO REPLACE THE WASTE PUMP TO RESOLVE THE LEAK AND THE COMPLETE BLOOD COUNT/DIFFERENTIAL VOTEOUTS. THE FSE ALSO FOUND THAT THE HEMOGLOBIN (HGB) LAMP GAIN WAS HIGH AND WAS UNABLE TO ADJUST THE VOLTAGE. THIS EVENT WAS NOT RELATED TO THE LEAK REPORTED BY THE CUSTOMER. THE FSE REPLACED THE HGB LAMP TO RESOLVE THE HGB LAMP GAIN ISSUE AND VERIFIED THE REPAIR AS PER ESTABLISHED PROCEDURES.

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE CONFIRMED A LEAK FROM THE NEEDLE AND THE COUPLING. THE FSE REPLACED THE NEEDLE ASSEMBLY AND THE COUPLING RESOLVING THE LEAK. SERVICE ACTIVITY WAS PERFORMED AND WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURE. PER LABELING, BECKMAN COULTER 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. BEC IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK OF APPROXIMATELY 30 ML OF DILUENT FROM THE COULTER® AC*T DIFF 2 ANALYZER. THE CUSTOMER ALSO OBTAINED COMPLETE BLOOD COUNT (CBC)/DIFFERENTIAL VOTEOUTS (NON-NUMERIC RESULTS) ON PATIENT SAMPLE RESULTS DURING THE EVENT. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING THAT APPROXIMATELY LESS THAN 5 MLS OF FLUID WAS LEAKING FROM THE NEEDLE AT THE LUER LOCK #1 FITTING. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT AT THE TIME OF OCCURRENCE. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED. THE LABORATORY'S EXPOSURE CONTROL/RISK MANAGEMENT PLANS ARE IN PLACE. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357001 COULTER AC*T DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER ACT DIFF 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1