C8000 PHOSPHORUS
Received Jul 23, 2007 · Event occurred Jul 6, 2007
Report 2018433-2007-00040 · MDR key 883527
Device
Generic name
Quantitation Of Phosphorus In Human Serum, Plasma Or Urine
Manufacturer
Abbott Manufacturing, Inc.Model number
NACatalog number
7D71-20
Lot number
48007HW00
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, HAVE SHIFTED LOW AFTER USING A NEW PHOSPHORUS ASSAY REAGENT LOT# 48007HW00. THIS ISSUE IS OCCURRING ON BOTH ARCHITECT C8000 ANALYZERS IN THE LAB. THE CUSTOMER STATED A NEW REAGENT (LOT# NOT GIVEN) WAS USED AND THE CONTROLS CAME IN RANGE. 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