MalfunctionCKA
SYNCHRON® ALANINE AMINOTRANSFERASE (ALT) 2 X 400 REAGENT KIT
Received Jan 24, 2012 · Event occurred Nov 4, 2011
Report 2050012-2012-00253 · MDR key 2426949
Device
Generic name
Nadh Oxidation/nad Reduction, Alt/sgpt
Manufacturer
Beckman Coulter Inc.Model number
CX/LX ALT KITCatalog number
176826
Lot number
M102143
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT UPON RECEIPT OF THE SYNCHRON ALANINE AMINOTRANSFERASE (ALT) 2 X 400 REAGENT LOT, THE CUSTOMER OBSERVED THAT ONE (1) REAGENT KIT WAS EMPTY AND WET WITH NO VISIBLE DAMAGE. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED FOR THIS EVENT.
Additional Manufacturer Narrative
THE CUSTOMER WAS SENT A REPLACEMENT. BEC IDENTIFIER FOR THIS REPORT IS (B)(4). DEFECTED DEVICE WAS REPLACED.