BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T 5 DIFF ANALYZER

    MDR report key: 2087777 · Received May 12, 2011

    Report

    Report Number
    1061932-2011-00403
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K030291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) HAD PERFORMED A PREVENTIVE MAINTENANCE (PM) ON THE INSTRUMENT A DAY BEFORE THE EVENT. CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING (TS), INCLUDING BLEACHING THE INSTRUMENT, VERIFYING REAGENT TUBING CONNECTIONS, PRIMING REGENTS, AND PERFORMING HARDWARE RESET. DURING THE RERUN OF THE PATIENT SAMPLES (RERUN PATIENT RESULTS SHOWN IN THE ATTACHMENT PORTION), THE CUSTOMER DISCOVERED A DISCONNECTED TUBE AROUND THE PROBE/BATH AREA WHICH THE CUSTOMER WAS NOT INITIALLY ABLE TO IDENTIFY TO RE-CONNECT. THE CUSTOMER REATTACHED THE TUBING. THE SERVICE REQUEST WAS CANCELED DUE TO THIS DISCOVERY. THE ROOT CAUSE FOR THE LEAK IS ATTRIBUTED TO THE TUBING WHICH WAS DISCONNECTED FROM THE PROBE. 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 IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT A FLUID LEAK WAS DISCOVERED ON THE COULTER ACT 5 DIFF ANALYZER AFTER THE CUSTOMER REPORTED GETTING ZEROES (0) OR NO RESULTS ON PATIENT SAMPLES WITH INSTRUMENT GENERATED FLAGS. NO ERRONEOUS RESULTS WERE REPORTED OUT AND THERE WAS NO AFFECT TO PATIENT TREATMENT. THE OPERATOR WAS WEARING THE PROPER PROTECTIVE EQUIPMENT (PPE). THE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN IN THE ATTACHMENT PORTION OF THIS REPORT. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO ONE SOUGHT MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER AC*T 5 DIFF ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. AC*T 5 DIFF AL N/A

    Patients

    Seq Age Sex Outcome Treatment
    1