COULTER 5C CELL CONTROL

Additional Manufacturer Narrative

PER LABELING, 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 IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LAB ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LAB ANALYZER. THE FIELD SERVICE ENGINEER INSPECTED THE INSTRUMENT AND VERIFIED THE INSTRUMENT'S OPERATION. THERE WERE NO ANOMALIES NOTED. BASED ON AVAILABLE INFO, THE ROOT CAUSE FOR THE VIAL LEAKING IS UNK. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JAN. 1, 2008 AND OCT. 23, 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

Description of Event or Problem

THE CUSTOMER REPORTED THAT A SINGLE COULTER 5C CELL CONTROL VIAL LEAKED THROUGH THE RUBBER STOPPER AND PLASTIC CAP WHILE ON THE ANALYZER'S ROCKER BED. THE POTENTIAL FOR BIOHAZARD EXPOSURE WITH THE REPORTED INCIDENT WAS PRESENT. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) AT THE TIME OF THE INCIDENT. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN LESIONS. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT AS A RESULT OF THIS EVENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED; HOWEVER, IT IS READILY AVAILABLE. THE LAB'S EXPOSURE CONTROL OR RISK MANAGEMENT PLANS ARE IN PLACE. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO OPERATOR SAFETY AS A RESULT OF THIS EVENT. THE PRODUCT WAS REPLACED AT TIME OF EVENT.