BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC-T DIFF 2 ANALYZER

    MDR report key: 2151516 · Received June 24, 2011

    Report

    Report Number
    1061932-2011-00719
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    January 4, 2008
    Report Date
    January 4, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2008, THE FIELD SERVICE ENGINEER REPLACED THE WBC BATH AND PROBE ASSEMBLY AND VERIFIED INSTRUMENT OPERATIONS. THE OPERATOR WAS IN THE PROCESS OF CLEANING THE BATHS AND REPLACING THE WBC CHECK VALVES WHEN SHE ACCIDENTALLY CLOSED THE CAP PIERCE DOOR AND PIERCED HER FINGER. THE OPERATOR DID NOT FOLLOW THE SERVICE AND MAINTENANCE PROCEDURES, REPLACING CHECK VALVES AND CLEANING THE CLOSED VIAL STATION LOCATED IN THE OPERATOR'S GUIDE INSTRUCTING HER TO TURN INSTRUMENT OFF PRIOR TO REPLACING CHECK VALVES. ROOT CAUSE WAS USER ERROR. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4), 2008 TO (B)(4), 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A MINOR INJURY SUSTAINED WHILE OPERATING THE COULTER AC-T DIFF 2 ANALYZER. WHILE TROUBLESHOOTING THE ANALYZER WITHOUT ASSISTANCE FROM BECKMAN COULTER INC PERSONNEL, THE OPERATOR ACCIDENTALLY PIERCED HER FINGER ON THE PROBE. THE OPERATOR WAS REPLACING THE PNEUMATIC CHECK VALVES ATTACHED TO THE WHITE BLOOD CELL (WBC) BATH AND SHE ACTIVATED THE ANALYZER RESULTING IN THE PROBE PIERCING HER FINGER. THE ANALYZER WAS POWERED ON AT THE TIME OF THE EVENT. THE OPERATOR WAS WEARING APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT. THE OPERATOR WAS TREATED BY A PHYSICIAN AND FIRST AID WAS ADMINISTERED. HER FINGER WAS BANDAGED. THE OPERATOR HAS SINCE TESTED NEGATIVE FOR INFECTIOUS DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER AC-T DIFF 2 ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK