MalfunctionCEO
C8000 PHOSPHORUS
Received Jul 24, 2007 · Event occurred Jun 25, 2007
Report 2018433-2007-00044 · MDR key 884215
Device
Generic name
Quantitation Of Phosphorus In Human Serum, Plasma Or Urine
Manufacturer
Abbott Manufacturing, Inc.Model number
NACatalog number
7D71-30
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
Description of Event or Problem
THE CUSTOMER WAS QUESTIONING PHOSPHORUS CONTROL VALUES RUN ON THE ARCHITECT C8000 ANALYZER. IT WAS DISCOVERED THAT THE CUSTOMER WAS USING INCORRECT TARGET VALUES THAT WERE OUT OF RANGE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Additional Manufacturer Narrative
AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.
Remedial action
- Other