COULTER 4C PLUS CELL CONTROL
Received Oct 28, 2011 · Event occurred Nov 11, 2009
Report 1061932-2011-01963 · MDR key 2320313
Device
Product problems
- Break
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER NOTICED THAT THE 4C PLUS NORMAL CONTROL CAP WAS OFF KILTER AND TRIED TO FIX IT WHEN THE TOP OF THE TUBE BROKE. THE TUBE TOP BROKE BUT NO CONTROL MATERIAL WAS SPILLED AND NO ONE WAS CUT OR OTHERWISE INJURED. THE 4C PLUS NORMAL CONTROL IS USED IN ASSOCIATION WITH THE ACT DIFF HEMATOLOGY ANALYZER. THE OPERATOR WAS WEARING GLOVES, LAB COAT AND GLASSES AT THE TIME OF THE EVENT. THERE WAS NO REPORTED EXPOSURE TO OPEN LESIONS OR MUCOUS MEMBRANES. NO ONE SOUGHT MEDICAL ATTENTION IN ASSOCIATION WITH THIS EVENT.
Additional Manufacturer Narrative
THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED FOR THE PERIOD BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. THE 4C PLUS CONTROL WAS REPLACED. THE ROOT CAUSE IS UNKNOWN. PER BECKMAN COULTER INC LABELING: BECAUSE NO TEST METHOD CAN OFFER COMPLETE ASSURANCE THAT (B)(4), OR OTHER INFECTIOUS AGENTS ARE ABSENT, THIS SPECIMEN/REAGENT SHOULD BE HANDLED AT BIOSAFETY LEVEL 2, AS RECOMMENDED FOR ANY POTENTIALLY INFECTIOUS HUMAN SERUM OR BLOOD SPECIMEN IN THE (B)(4).