MalfunctionCKA
SYNCHRON® IRON / TIBC CALIBRATOR
Received Jul 28, 2011 · Event occurred Jun 29, 2011
Report 2050012-2011-03859 · MDR key 2182574
Device
Generic name
Lipase Test System
Manufacturer
Beckman Coulter, Inc.Model number
NACatalog number
442772
Lot number
0206071
Product problems
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER WAS SENT A REPLACEMENT. BEC IDENTIFIER FOR THIS REPORT IS (B)(4).
Description of Event or Problem
A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THEY RECEIVED A SYNCHRON IRON/IBCT CALIBRATOR THAT WAS LEAKING FROM A LOOSE CAP. NO INJURY WAS REPORTED IN CONNECTION WITH THIS EVENT.