MalfunctionCKA
ASPARTATE AMINOTRANSFERASE
Received Nov 1, 2010 · Event occurred Oct 12, 2010
Report 2050012-2010-01102 · MDR key 1887028
Device
Generic name
Aspartate Aminotransferase Reagent
Manufacturer
Beckman Coulter Inc.Catalog number
476831
Lot number
M003677
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING AN ASPARTATE AMINOTRANSFERASE (AST) REAGENT CARTRIDGE THAT WAS LEAKING INSIDE THE BOX. THE PACKAGE INSERT WAS WET. THE CUSTOMER WAS WEARING PERSONA PROTECTIVE EQUIPMENT (PPE). NO INJURY WAS REPORTED ON THIS ISSUE.
Additional Manufacturer Narrative
CUSTOMER WAS SENT REPLACEMENT.
Remedial action
- Replace