MalfunctionCFJ
LD REAGENT
Received Apr 14, 2011 · Event occurred Mar 15, 2011
Report 2050012-2011-00913 · MDR key 2058197
Device
Generic name
Ld Reagent
Manufacturer
Beckman Coulter Inc.Model number
NACatalog number
442655
Lot number
M011542
Product problems
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THIS EVENT.
Description of Event or Problem
IT WAS REPORTED THAT THE LACTATE DEHYDROGENASE (LD) REAGENT LEAKED THOUGH THERE WAS NOT LOOSENING OF THE CAP. THE EVENT OCCURRED AT THE BECKMAN COULTER INC., (BCI) WAREHOUSE IN JAPAN. NO INJURY WAS REPORTED ON THIS ISSUE.