MalfunctionCKA
SYNCHRON GGT REAGENT
Received Jan 3, 2011 · Event occurred Dec 3, 2010
Report 2050012-2011-00024 · MDR key 1945112
Device
Generic name
Gamma-glutamyl Transpeptidase Reagent
Manufacturer
Beckman Coulter Inc.Model number
NACatalog number
442650 (FOR THE REAGENT)
Lot number
M003634
Product problems
- Leak/Splash
- Device Slipped
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER WAS SENT A REPLACEMENT.
Description of Event or Problem
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING A GAMMA-GLUTAMYL TRANSFERASE (GGT) REAGENT CARTRIDGE LEAKED DUE TO LOOSE CAPS. NO INJURY WAS REPORTED.
Remedial action
- Replace