MalfunctionCEO
C8000 PHOSPHORUS
Received Jul 23, 2007 · Event occurred Dec 27, 2006
Report 2018433-2007-00042 · MDR key 883524
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
Additional Manufacturer Narrative
THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem
THE CUSTOMER STATED THAT PHOSPHATE CONTROL VALUES, RUN ON THE ARCHITECT C8000 ANALYZER, HAS SHIFTED UP AND IS OUT OF RANGE ON THE PHOSPHATE REAGENT LOT# 40460M200. THE CUSTOMER ADDED THE CORRECT CALIBRATOR VALUE IN THE ASSAY FILE AND RECEIVED ACCEPTABLE RESULTS. THERE WAS NO IMPACT TO PT MANAGEMENT REPORTED.
Remedial action
- Other