SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGENT
Received Nov 17, 2011 · Event occurred Jan 19, 2011
Report 2050012-2011-07618 · MDR key 2340851
Device
Generic name
Nadh Oxidation/nad Reduction, Alt/sgpt
Manufacturer
Beckman Coulter, Inc.Catalog number
445865
Lot number
T102156
Product problems
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
ON (B)(6) 2011, CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE WASH CONCENTRATE BOTTLE ON THE SYNCHRON CX DELTA CLINICAL SYSTEM (CX 9) WAS LEAKING. CUSTOMER REPORTED THAT THE BOTTLE LEAKED BEFORE IN (B)(6), 2011. THERE WAS NO REPORT OF ERRONEOUS RESULTS GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT.
Additional Manufacturer Narrative
THIS REPORT IS ONE OF TWO REPORTS RELATED TO TWO EVENTS THAT OCCURRED ON TWO DIFFERENT DAYS. BEC IDENTIFIER FOR THIS COMPLAINT IS (B)(4).