MalfunctionCEO
C8000 PHOSPHORUS
Received Jul 24, 2007 · Event occurred Dec 23, 2006
Report 2018433-2007-00045 · MDR key 884214
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
YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER STATED THAT THE URINE PHOSPHATE CONTROL VALUES, RUN ON THE ARCHITECT C8000 ANALYZER, ARE OUT OF RANGE. THE CUSTOMER CHANGED THE SALINE TO NON-PHOSPHATE BUFFERED SALINE AND RECEIVED ACCEPTABLE RESULTS. 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