C8000 PHOSPHORUS
Received Jul 23, 2007 · Event occurred Dec 29, 2006
Report 2018433-2007-00037 · MDR key 883536
Device
Generic name
Quanitation 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
Description of Event or Problem
THE CUSTOMER STATED THAT THE URINE PHOSPHORUS CONTROL VALUES, RUN ON THE ARCHITECT C8000 ANALYZER, ARE OUT OF RANGE ON TWO LEVELS OF CONTROLS AFTER USING THE PHOSPHORUS REAGENT LOT# 42020HW00. THE CUSTOMER REPLACED THE PHOSPHATE BUFFER SALINE WITH SALINE THAT WAS NOT PHOSPHATE BUFFERED AND RECEIVED ACCEPTABLE RESULTS. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Additional Manufacturer Narrative
THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.
Remedial action
- Other