MalfunctionCKA
DXC 800 PRO REAGENT
Received Apr 21, 2011 · Event occurred Mar 22, 2011
Report 2050012-2011-01045 · MDR key 2066337
Device
Generic name
Dxc 800 Pro Reagent
Manufacturer
Beckman Coulter Inc.Model number
N/ACatalog number
442665
Lot number
T010139
Product problems
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT THAT ONE (1) DXC 800 PRO AST REAGENT PACK LEAKED ALL OUT ON ARRIVAL. REAGENT PACK WAS EMPTY. NO EFFECT TO USER WAS REPORTED WITH THIS EVENT.
Additional Manufacturer Narrative
A REPLACEMENT WAS SENT TO THE CUSTOMER. A CLEAR ROOT CAUSE IS UNKNOWN AT THIS TIME.
Remedial action
- Replace