C8000 PHOSPHORUS
Received Jul 23, 2007 · Event occurred Feb 22, 2007
Report 2018433-2007-00036 · MDR key 883537
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
Description of Event or Problem
THE CUSTOMER STATED THAT THE PHOSPHORUS CONTROL VALUE, RUN ON THE ARCHITECT C8000 ANALYZER, IS OUT OF RANGE AND A CORRECT RESULT IS GENERATED AFTER DILUTING THE CONTROL. THIS ISSUE IS OCCURRING WITH THE PHOSPHORUS REAGENT LOT# 42020HW00. THE CUSTOMER USED A NEW LOT OF PHOSPHORUS REAGENT (LOT# NOT GIVEN) 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