CLINICAL CHEMISTRY IRON
Received Sep 17, 2008 · Event occurred Sep 1, 2008
Report 2018433-2008-00185 · MDR key 1171505
Device
Generic name
For The Quantitation Of Iron In Human Serum
Manufacturer
Abbott Manufacturing, Inc.Model number
NACatalog number
7D68-30
Lot number
60030HW00
Product problems
- Incorrect Or Inadequate Test Results
Patient
NI
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
THE ACCOUNT STATED THAT THE RESULTS FROM THE ARCHITECT IRON ASSAY ARE NON-REPRODUCIBLE. FOR PATIENT #2, THE INITIAL RESULT= 6 UG/DL, THE SAMPLE WAS THEN TESTED IN DUPLICATE AND BOTH RESULTS WERE 15 UG/DL. THE ACCOUNT STATES THE INITIAL RESULT WHICH IS TOO LOW IS THE INCORRECT RESULT. 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 COMPLETE.
Additional Manufacturer Narrative
(B)(4). THE CUSTOMER WAS COMPLAINING OF IRON REPRODUCIBILITY ISSUES. MAINTENANCE WAS UP TO DATE. CUSTOMER USING CLINICAL CHEMISTRY IRON, LN 7D68-30, EXP 10/30/2008 AND IRON/MG CALIBRATOR, LN 1E69-03, EXP 6/9/2008. IT WAS LATER IDENTIFIED THE CUSTOMER WAS USING EXPIRED CALIBRATORS WHEN THE SUSPECT RESULTS WERE GENERATED. REVIEW THE CLINICAL CHEMISTRY IRON/ MAGNESIUM CALIBRATOR PACKAGE INSERT COMMODITY #(B)(4) WAS PERFORMED. PAGE 1, "WARNINGS AND PRECAUTIONS" SECTION STATES; "DO NOT USE COMPONENTS BEYOND THE EXPIRATION DATE". REVIEW OF THE ABBOTT METRIC REPORTS INDICATED NO SIMILAR COMPLAINTS WERE FOUND. THIS IS THE FINAL REPORT.