COULTER 5C CELL CONTROL

Additional Manufacturer Narrative

THE ABNORMAL II VIAL HAD BEEN PIERCED OVER THIRTEEN (13) TIMES. THE OPEN VIAL CLAIM AS STATED IN THE TABLE OF EXPECTED RESULTS IS THIRTEEN TIMES (13) TIMES WITHIN THIRTEEN (13) DAYS. THE OTHER TWO CONTROL LEVELS WITHIN THE KIT DID NOT EXHIBIT THIS ISSUE. PRODUCT LABELING STATES: "THIS SPECIMEN/REAGENT SHOULD BE HANDLED AT BIOSAFETY LEVEL 2, AS RECOMMENDED FOR ANY POTENTIALLY INFECTIOUS HUMAN SERUM OR BLOOD SPECIMEN IN THE CENTERS FOR (B)(4) "BIOSAFETY IN MICROBIOLOGICAL AND BIOMEDICAL LABORATORIES," 1988." EVAL OF CUSTOMER RETURN PRODUCT BY A PACKAGE ENGINEER CONCLUDED THAT THE STOPPER EXHIBITED AN UNUSUAL HOLE AT THE STOPPER PIERCE SITE AND THE STOPPER HOLE DOES PERMIT PRODUCT TO ESCAPE. ON (B)(6) 2008, THE FIELD SERVICE ENGINEER EVALUATED THE COULTER MAXM W/AUTOLOADER (INCLUDING NEEDLE ALIGNMENT). ANALYZER MET PUBLISHED PERFORMANCE SPECIFICATIONS AND DID NOT REQUIRE ANY ADJUSTMENT. ROOT CAUSE WAS DETERMINED TO BE USER ERROR. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(6) 2008 AND (B)(6) 2010 OF COMPLAINTS FOR ADD'L 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 1061932-2011-00761.

Description of Event or Problem

CUSTOMER REPORTED A POTENTIAL BIOHAZARD EVENT WHEN USING THE COULTER 5C CELL CONTROL. THE ABNORMAL II VIAL IN THE KIT WAS EXHIBITING A SLOW DRIP WHEN INVERTED. THIS DRIP WAS FROM THE CAP AND OCCURRED AFTER 13 PIERCES. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AT THE TIME OF THE INCIDENT. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN LESIONS. 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 FOR THE FIRST OF TWO LOTS.