MalfunctionCFJ
SYNCHRON® LD 2 X 300
Received May 6, 2011 · Event occurred Apr 6, 2011
Report 2050012-2011-01298 · MDR key 2080703
Device
Generic name
Lactate Dehyrogenase Enzyme Test System
Manufacturer
Beckman Coulter, Inc.Model number
NACatalog number
476841
Lot number
Z101228
Product problems
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
REPLACEMENT KIT WAS SENT TO THE CUSTOMER.
Description of Event or Problem
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A REAGENT LEAK FROM SYNCHRON LD CARTRIDGE. THERE WAS NO EXPOSURE TO UNCOVERED WOUNDS OR MUCOUS MEMBRANES. NO INJURY WAS REPORTED.
Remedial action
- Replace