MalfunctionJZJ
SYNCHRON® PREALBUMIN (PAB) TEST KIT
Received Mar 19, 2011 · Event occurred Feb 12, 2011
Report 2050012-2011-00794 · MDR key 2024491
Device
Generic name
Prealbumin Reagent
Manufacturer
Beckman Coulter Inc.Model number
NACatalog number
475106
Lot number
M010391
Product problems
- Crack
- Fluid/Blood Leak
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER.
Description of Event or Problem
THE USER REPORTED THAT ONE OF THE SYNCHRON PREALBUMIN (PAB) TEST KIT WAS LEAKING DUE TO A CRACK. THE CUSTOMER DID NOT REPORT ANY USER INJURY OR MEDICAL INTERVENTION IN ASSOCIATION TO THIS EVENT.