SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGENT
Received Nov 17, 2011 · Event occurred Oct 19, 2011
Report 2050012-2011-07617 · MDR key 2340846
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
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 THERE WAS A FINE CRACK ON THE CONTAINER.CUSTOMER REPORTED THAT THE CONTAINER HAS BEEN ON THE CX 9 FOR ONE WEEK.BEC CUSTOMER TECHNICAL SPECIALIST SENT CUSTOMER A REPLACEMENT BOTTLE OF WASH CONCENTRATE.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. THIS MDR IS RELATED TO MDR# 2050012-2011-07618.BEC IDENTIFIER FOR THIS COMPLAINT IS (B)(4).