inforMED
MalfunctionCEK

SYNCHRON CX TOTAL PROTEIN REAGENT

Received Dec 10, 2010 · Event occurred Nov 18, 2010

Report 2050012-2010-01642 · MDR key 1918974

Device

Generic name

Total Protein Reagent

Model number

NA

Catalog number

442740

Lot number

Z007007

Product problems

  • Break
  • Leak/Splash
  • Device Damaged Prior to Receipt by User

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT CX TOTAL PROTEIN (TP) REAGENT BOTTLES WERE RECEIVED BROKEN AND LEAKING. NO INJURY WAS REPORTED.

Additional Manufacturer Narrative

THE CUSTOMER WAS SENT REPLACEMENT.

Remedial action

  • Replace