BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT¿ 5DIFF AUTOLOADER (AL)

    MDR report key: 3080042 · Received April 26, 2013

    Report

    Report Number
    1061932-2013-00726
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K030291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) OBSERVED THE TUBING WAS OFF ON THE TOP OF PINCH VALVE LV12. THE FSE REPLACED THE VALVE ASSEMBLY FOR PINCH VALVE LV1-12 AND RESOLVED THE ISSUE. THE INSTRUMENT WAS VERIFIED WITH LATEX CHECKS, REPRODUCIBILITY, STARTUP AND QUALITY CONTROL (QC); NO FURTHER ISSUES WERE NOTED. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY FIFTY (50) MILLILITERS OF UNKNOWN FLUID LEAKED FROM THE COULTER ACT 5DIFF AUTOLOADER (AL) ANALYZER AND ONTO THE COUNTER. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. PATIENT RESULTS WERE NOT IMPACTED. THERE WAS NO PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT. THE LABORATORY HAS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN IN PLACE. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181385 COULTER® ACT¿ 5DIFF AUTOLOADER (AL) COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1