MalfunctionCFJ
VR*CX/LX LD
Received Sep 15, 2010 · Event occurred Aug 23, 2010
Report 2050012-2010-00727 · MDR key 1836062
Device
Generic name
Lactate Dehydrogenase
Manufacturer
Beckman Coulter Inc.Model number
NACatalog number
476841(RG PN)
Lot number
Z006005
Product problems
- Fluid/Blood Leak
- Hole In Material
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
CUSTOMER WAS CONTACTED AND CONFIRMED THERE WAS A SMALL CRACK IN THE CAP FOR COMPARTMENT A. CUSTOMER DID NOT REPORT SYSTEM ISSUE. CUSTOMER WAS SENT REPLACEMENT.
Description of Event or Problem
CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) STATING THAT A SMALL HOLE ON THE CAP OF THE BOTTLE LEAD TO LEAKAGE OF THE REAGENT. NO INJURY WAS REPORTED ON THIS ISSUE.
Remedial action
- Replace