BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC.T DIFF2 ANALYZER

    MDR report key: 2468346 · Received February 24, 2012

    Report

    Report Number
    1061932-2012-00671
    Event Type
    Malfunction
    Date Received
    February 24, 2012
    Date of Event
    February 3, 2012
    Report Date
    February 3, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE ISSUE WAS A WASTE CONTAINER THAT BEGAN TO LEAK, AND REQUIRED REPLACEMENT DUE TO WEAR. THE CTS INSTRUCTED CUSTOMER AS TO HOW TO REPLACE THE WASTE CONTAINER, THEN CONFIRMED PROPER INSTRUMENT FUNCTION WITH CUSTOMER. CUSTOMER HAS NOT CALLED BACK TO REPORT ANY FURTHER ISSUES. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT THE BOTTOM OF THE WASTE CONTAINER OF THE COULTER AC.T DIFF2 ANALYZER LEAKED APPROXIMATELY SIX OUNCES OF FLUID. CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LABORATORY COAT AND GLOVES. CUSTOMER DID NOT COME IN CONTACT WITH THE FLUID, AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS, AND NO ONE WAS SPLASHED OR SPRAYED. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR ASSOCIATED WITH THIS COMPLAINT. THERE WAS NO IMPACT TO PATIENT SAMPLES OR RESULTS. THE CUSTOMER TECHNICAL SPECIALIST (CTS) DETERMINED THAT THE WASTE CONTAINER REQUIRED PLACEMENT DUE TO WEAR. THE CTS EXPLAINED TO CUSTOMER, VIA TELEPHONE, THAT A NEW WASTE CONTAINER COULD BE PURCHASED, OR THAT CUSTOMER MAY ALSO OPT TO RE-USE ANY EMPTY DILUENT CONTAINER. CUSTOMER CHOSE TO RE-USE AN EMPTY DILUENT CONTAINER. THE CTS INSTRUCTED CUSTOMER TO RELABEL THE CONTAINER AS WASTE FOR CLEAR IDENTIFICATION OF ITS USE. THE REPLACEMENT OF THE WASTE CONTAINER RESOLVED THE LEAK ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER AC.T DIFF2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. AC.T DIFF2

    Patients

    Seq Age Sex Outcome Treatment
    1