BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER 4C-ES CELL CONTROL, NORMAL

    MDR report key: 2326262 · Received October 21, 2011

    Report

    Report Number
    1061932-2011-01905
    Event Type
    Malfunction
    Date Received
    October 21, 2011
    Date of Event
    May 26, 2010
    Report Date
    May 26, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JPK
    PMA / PMN Number
    K010064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT LABELING STATES: "BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER." SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE WAS NOT DETERMINED. PRODUCT LABELING CONTAINS SUFFICIENT WARNINGS/PRECAUTIONS ADDRESSING POTENTIAL BIOHAZARD EVENTS. 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

    A COMPANY REPRESENTATIVE FROM THE BECKMAN COULTER, INC. WAREHOUSE IN (B)(4) HAD CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT OBSERVING BLOOD ADHERED TO THE PACKAGING OF A COULTER 4C-ES CELL CONTROL, NORMAL DURING INCOMING QC INSPECTION. A DIGITAL PHOTOGRAPH PROVIDED BY THE COMPANY REPRESENTATIVE REVEALED A SMALL SPOT OF BLOOD ON THE INNER PLASTIC TRAY OF THE PACKAGING. THE COMPANY REPRESENTATIVE WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AT THE TIME OF THE EVENT. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN LESIONS. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. MEDICAL ATTENTION WAS NOT SOUGHT. THE COMPANY REPRESENTATIVE REPORTED THAT THE FACILITY HAS A RISK MANAGEMENT PLAN IN PLACE. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS REVIEWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER 4C-ES CELL CONTROL, NORMAL JPK BECKMAN COULTER, INC. NA 1004111F

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK