MalfunctionCEO
C8000 PHOSPHORUS
Received Jul 23, 2007 · Event occurred Jan 12, 2007
Report 2018433-2007-00041 · MDR key 883526
Device
Generic name
Quantitation Of Phosphorus In Human Serum, Plasma Or Urine
Manufacturer
Abbott Manufacturing, Inc.Model number
NACatalog number
7D71-20
Lot number
42020HW00
Product problems
- Unknown (for use when the device problem is not known)
Patient
NI YR
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem
THE CUSTOMER STATED THAT THE BIORAD QUALITY CONTROL VALUES, RUN ON THE ARCHITECT C8000 ANALYZER, WERE HAVING A HIGHER RECOVERY THAN THE BIORAD PEER GROUP VALUES. THERE WAS NO IMPACT TO PT MANAGEMENT REPORTED.
Remedial action
- Other