COULTER® 4C® PLUS CELL CONTROL
Received Jan 11, 2011 · Event occurred Dec 10, 2010
Report 1061932-2011-00010 · MDR key 1958061
Device
Generic name
Hematology Quality Control Mixture
Manufacturer
Beckman Coulter, Inc.Model number
NACatalog number
7547114
Lot number
1000368K
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.
Description of Event or Problem
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A COULTER 4C PLUS CELL LOW CONTROL TUBE THAT LEAKED. WHILE MIXING TUBE PER PACKAGE INSERT INSTRUCTION, THE CAP AND SOME OF THE CONTROL MATERIAL SPILLED ONTO THE FLOOR. THE CONTROL VIALS WERE BEING USED FOR THE FIRST TIME. THE OTHER TWO LEVELS OF CONTROL TUBES WERE CLOSED PROPERLY. THE CUSTOMER WAS WEARING GLOVES AND LAB COAT. THERE WAS NO EXPOSURE TO OPEN LESION OR MUCOUS MEMBRANES, AND NO ONE SOUGHT MEDICAL ATTENTION. THERE WAS NO EFFECT TO PATIENT OR USER.