COULTER 5C CELL CONTROL

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. 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 2 OF 2 EVENTS REPORTED BY THIS CUSTOMER FOR THE SECOND OF TWO LOTS.

Additional Manufacturer Narrative

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 DISEASE CONTROL/NATIONAL INSTITUTES OF HEALTH MANUAL "BIOSAFETY IN MICROBIOLOGICAL AND BIOMEDICAL LABORATORIES," 1988." A CUSTOMER RETURN WAS NOT AVAILABLE FOR EVAL FOR THIS LOT. ANOTHER LOT USED BY THE SAME CUSTOMER WAS EVALUATED. A SMALL HOLE WAS IDENTIFIED IN THE STOPPER OF THE VIAL WHICH COULD PERMIT LIQUID TO LEAK. ON (B)(4) 2008, THE FIELD SERVICE ENGINEER EVALUATED THE COULTER MAXM W/AUTOLOADER (INCLUDING NEEDLE ALIGNMENT). THE 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)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. THIS MDR REPRESENTS EVENT 2 OF 2 REPORTED BY THIS CUSTOMER. THIS MDR IS RELATED TO THE FOLLOWING MDRS THAT HAVE BEEN REPORTED: MDR 1061932-2011-00748.