MalfunctionCKA
SYNCHRON IRON/IBCT CALIBRATOR
Received Nov 8, 2011 · Event occurred Oct 12, 2011
Report 2050012-2011-07382 · MDR key 2328537
Device
Generic name
Calibrator, Secondary
Manufacturer
Beckman Coulter, Inc.Model number
FE/IBCT CALIBRATORCatalog number
442772
Lot number
58891101
Product problems
- Leak/Splash
- Device Slipped
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
A BECKMAN COULTER, INC. REPRESENTATIVE REPORTED ON A SYNCHRON IRON/IBCT (TOTAL IRON BUILDING CAPACITY) CALIBRATOR LEAK, DUE TO A LOOSE CAP. THE REAGENT WAS QUARANTINED AND NO ONE WAS AFFECTED BY THE REAGENT LEAK.
Additional Manufacturer Narrative
THE BECKMAN COULTER, INC. IDENTIFIER FOR THIS REPORT IS (B)(4).