CLINICAL CHEMISTRY IRON
Received Mar 18, 2008 · Event occurred Feb 13, 2008
Report 2018433-2008-00031 · MDR key 1016481
Device
Generic name
Quantitation Of Iron
Manufacturer
Abbott Laboratories, Inc.Model number
NACatalog number
7D68-20
Lot number
56055HW00
Product problems
- Incorrect Or Inadequate Test Results
Patient
2 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE ACCOUNT GENERATED A DEPRESSED ARCHITECT C8000 IRON RESULT ON A PT THAT DID NOT CORRELATE WITH OTHER METHODS. THE PT TESTED ARCHITECT C8000 IRON = 7 UG/DL, ROCHE METHOD = 42 UG/DL AND KOVALENTE METHOD = 40 UG/DL. THE DEPRESSED ARCHITECT C8000 IRON RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. NO IMPACT TO PT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
INVESTIGATION IN PROCESS, NO RESULTS OR CONCLUSION CAN BE DRAWN. THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.