MalfunctionCKA
SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGENT
Received Dec 4, 2011 · Event occurred Nov 2, 2011
Report 2050012-2011-08228 · MDR key 2357088
Device
Generic name
Nadh Oxidation/nad Reduction, Alt/sgpt
Manufacturer
Beckman Coulter Inc.Model number
CX/LX ALT KITCatalog number
76826
Lot number
M102143
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER CONTACTED BECKMAN COULTER INC TO REPORT SYNCHRON ALT 2 X 400 REAGENT WAS LEAKING FROM UNKNOWN SOURCE. THE CUSTOMER DID NOT COME IN CONTACT WITH THE FLUID; NO EXPOSURE (SPRAYED OR SPLASHED) TO MUCOUS MEMBRANES. NO DEATH, INJURY OR CHANGES TO PATIENT RESULT OR TREATMENT ARE ASSOCIATED WITH THIS EVENT. THE REAGENT IS SKIN, EYE AND RESPIRATORY TRACT IRRITANT. CONTAINS MATERIAL OF ANIMAL ORIGIN.
Additional Manufacturer Narrative
(B)(4).