COULTER® 4C® PLUS CELL CONTROL

Description of Event or Problem

A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A COULTER 4C PLUS CELL NORMAL CONTROL VIAL THAT LEAKED. THE VIAL LEAKED ON A TISSUE PAPER INSIDE THE REFRIGERATOR, AND NO OTHER AREAS WERE CONTAMINATED. THIS WAS SECOND TIME AFTER THE INCIDENT ON (B)(6) 2010 (MEDWATCH REPORT #1061932-2010-00318). THE CUSTOMER SUSPECTS THE CONTROL LEAKED OUT OF THE RUBBER CAP WHEN IT WAS INADVERTENTLY KNOCKED OVER SINCE IT HAD A LARGER THAN NORMAL PUNCTURE HOLE. AFTER EACH SPILL, THE CUSTOMER FOLLOWED THE LAB PROCEDURE TO CLEAN UP BIOHAZARD MATERIAL, WEARING PROPER PERSONAL PROTECTIVE EQUIPMENT. IT IS UNKNOWN IF MSDS WAS REVIEWED, BUT IT IS AVAILABLE. NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS WAS REPORTED. NO ONE SOUGHT MEDICAL ATTENTION DUE TO THIS INCIDENT AND THERE WAS NO DEATH OR INJURY ATTRIBUTED TO THIS EVENT.

Additional Manufacturer Narrative

ACCORDING TO THE CUSTOMER'S QUALITY CONTROL FILE, THE VIAL HAD BEEN RUN 26 TIMES BEFORE THE FIRST LEAK AND 7 MORE TIMES BEFORE THE SECOND LEAK. THE CUSTOMER STOPPED USING THE VIAL ON (B)(6) 2010 AND THE PRODUCT WAS RETURNED FOR ANALYSIS. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.