COULTER AC.T 5DIFF WBC LYSE

Additional Manufacturer Narrative

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)(6) 2008 AND (B)(6) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

Description of Event or Problem

A COMPANY REPRESENTATIVE FROM THE BECKMAN COULTER, INC. WAREHOUSE IN (B)(4) HAD CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT OBSERVING A SMALL VOLUME OF LIQUID ADHERED TO CONTAINER OF A COULTER AC.T 5DIFF WBC LYSE DURING INCOMING QC INSPECTION. A DIGITAL PHOTOGRAPH PROVIDED BY THE COMPANY REPRESENTATIVE REVEALED A SMALL RESIDUAL STAIN ON THE CONTAINER. 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.