MalfunctionCKA
SYNCHRON CX TOTAL PROTEIN REAGENT
Received Jun 10, 2011 · Event occurred May 13, 2011
Report 2050012-2011-02137 · MDR key 2120605
Device
Generic name
Total Protein Reagent
Manufacturer
Beckman Coulter Inc.Model number
NACatalog number
442740
Lot number
M103163
Product problems
- Leak/Splash
- Loose or Intermittent Connection
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
REPLACEMENT REAGENT WAS SENT.
Description of Event or Problem
A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) AND REPORTED THAT TOTAL PROTEIN (TP) REAGENT CARTRIDGE WAS LEAKING AND THE CUSTOMER THOUGHT IT APPEARED THAT THE CAPS WERE LOOSE. NO INJURY WAS REPORTED ON THIS ISSUE.
Remedial action
- Replace