BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TETRA CXP SYSTEM FOR THE CYTOMICS FC 500 WITH CXP SOFTWARE

    MDR report key: 2152322 · Received June 24, 2011

    Report

    Report Number
    1061932-2011-00723
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    January 24, 2008
    Report Date
    January 24, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K030828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE CUSTOMER REFERENCE MANUAL ((B)(4)), STATES THAT THE FRONT COVER MUST BE OPENED WHEN CHANGING THE REAGENTS, THE INSTRUMENTAL MANUAL WARNS OF A RISK OF INJURY TO THE OPERATOR IF ALL DOORS, COVERS AND PANELS ARE NOT CLOSED AND SECURED IN PLACE PRIOR TO AND DURING INSTRUMENT OPERATION. SERVICE WAS NOT REQUIRED. ROOT CAUSE WAS USER ERROR. PRODUCT LABELING WAS EVALUATED AND FOUND TO BE SUFFICIENT. THE COMPLAINT HISTORY WAS REVIEWED AT THE TIME OF THE INCIDENT AND THIS WAS FOUND TO BE AN ISOLATED OCCURRENCE. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4), 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A MINOR INJURY WHILE USING THE FC 500 FLOW CYTOMETER. WHILE THE BECKMAN COULTER FIELD SERVICE REPRESENTATIVE WAS SHOWING THE OPERATOR HOW TO CHANGE THE REAGENTS IN THE INSTRUMENT, THE OPERATOR BENT DOWN AND UPON RISING, HIT HER HEAD ON THE OPEN FRONT COVER OF THE INSTRUMENT CAUSING A DERMABRASION TO THE FOREHEAD AND NOSE. THE OPERATOR WAS TREATED WITH FIRST AID BY PLACING A BANDAGE ON HER FOREHEAD. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. THE OPERATOR WAS WEARING LAB CLOTHES AND GLOVES AND THERE WAS NO EXPOSURE TO AN OPEN WOUND RESULTING FROM THIS INJURY. NO REPORTS OF DEATH OR SERIOUS INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TETRA CXP SYSTEM FOR THE CYTOMICS FC 500 WITH CXP SOFTWARE GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK