SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGENT
Received Dec 7, 2011 · Event occurred Nov 7, 2011
Report 2050012-2011-08202 · MDR key 2361378
Device
Generic name
Hexokinase, Glucose
Manufacturer
Beckman Coulter, Inc.Catalog number
442640
Lot number
M110149
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
GLUCOSE REAGENT CONTAINS MATERIAL OF ANIMAL ORIGIN AND SHOULD BE CONSIDERED POTENTIALLY INFECTIOUS.THIS REPORT IS ONE OF THREE REPORTS RELATED TO THREE EVENTS THAT OCCURRED ON THE SAME DAY. THIS REPORT IS RELATED TO MDR#2050012-2011-08192 AND MDR#2050012-2011-08203.BEC IDENTIFIER FOR THIS COMPLAINT IS (B)(4).
Description of Event or Problem
CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT GLUCOSE (LOT # M110149) REAGENT CARTRIDGE LEAKED FROM THE BOTTOM SEAM. CUSTOMER REPORTED THAT ERRONEOUS RESULTS WERE NOT GENERATED.THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT.