BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT DIFF 2 ANALYZER

    MDR report key: 2171234 · Received July 1, 2011

    Report

    Report Number
    1061932-2011-00787
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    April 2, 2008
    Report Date
    April 2, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE COULTER ACT DIFF 2 ANALYZER THAT WAS USED WITH THESE CONTROLS. THE FSE REPLACED THE PROBE AND RINSE BLOCK. ROOT CAUSE FOR THE LEAKING VIAL WAS DETERMINED TO BE DUE THE INSTRUMENT PROBE. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4), 2008 AND (B)(4), 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. THIS MDR REPRESENTS EVENT 2 OF 2 REPORTED BY THIS CUSTOMER. THIS MDR IS RELATED TO THE FOLLOWING MDRS THAT HAVE BEEN REPORTED: MDR 1061932-2011-00777.

    Description of Event or Problem · 1

    CUSTOMER REPORTED POTENTIAL BIOHAZARD WHEN THE VIALS OF ALL LEVELS OF CONTROLS IN THE 4C -ES CELL CONTROL KIT WERE LEAKING. THE CONTROLS WERE BEING USED ON A COULTER ACT DIFF 2 ANALYZER. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AND OBSERVED HAZARDOUS MATERIAL CLEAN-UP PROCEDURES. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN LESIONS. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO OPERATOR SAFETY AS A RESULT OF THIS EVENT. THIS EVENT REPRESENTS EVENT 2 OF 2 EVENTS REPORTED BY THIS CUSTOMER. THE OTHER EVENT IS A MALFUNCTION ASSOCIATED WITH THE 4C -ES CELL CONTROL VIALS FOR BROKEN CAPS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK 4C -ES CELL CONTROL