BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4C -ES CELL CONTROL

    MDR report key: 2171214 · Received July 1, 2011

    Report

    Report Number
    1061932-2011-00777
    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
    JPK
    PMA / PMN Number
    K010064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER INDICATED THE CAPS ARE BREAKING UP WHEN VIALS WERE CHANGED AND ALSO LEAKING AFTER THE FIRST USE. THE OLD VIAL WAS DISCARDED BY THE CUSTOMER. REQUESTED RETURN OF THE NEW VIAL FOR EVAL. RETURN PRODUCT WAS NOT RECEIVED FOR EVAL. COMPLAINT HISTORY WAS REVIEWED. THERE HAVE BEEN NO COMPLAINTS FOR CAPS BREAKING IN THE PAST 12 MONTHS. THERE IS NO KNOWN ROOT CAUSE FOR THE CAPS OF THE CONTROL VIALS BREAKING. 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 1 OF 2 REPORTED BY THIS CUSTOMER. THIS MDR IS RELATED TO THE FOLLOWING MDRS THAT HAVE BEEN REPORTED: MDR 1061932-2011-00787.

    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 DUE TO BROKEN CAPS. 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 1 OF 2 EVENTS REPORTED BY THIS CUSTOMER. THE OTHER EVENT IS A MALFUNCTION OF THE ANALYZER USED WITH THESE CONTROLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4C -ES CELL CONTROL JPK BECKMAN COULTER, INC. NA 1685080K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK COULTER ACT DIFF 2 ANALYZER