ARCHITECT CEA
Received Apr 15, 2011 · Event occurred Mar 21, 2011
Report 1415939-2011-00116 · MDR key 2059740
Device
Generic name
For The Determination Of Carcinoembryonic Antigen In Serum Or Plasma
Manufacturer
Abbott LaboratoriesCatalog number
6C02-20
Lot number
83397M500
Product problems
- Low Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
Additional Manufacturer Narrative
(B)(4). TESTING WAS PERFORMED USING AN IN-HOUSE FILE KIT OF ARCHITECT CEA LOT 83397M500. ONE INSTRUMENT WAS CALIBRATED AND SINGLE REPLICATES OF QUALITY CONTROLS WERE RUN. TO EVALUATE THE ACCURACY OF THE ASSAY TWO RUNS OF 15 REPLICATES OF CEA PANEL MEMBERS 1, 2 AND 5 WERE TESTED. THE GRAND MEANS OF EACH CEA PANEL MEMBER WERE WITHIN SPECIFICATIONS. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THE ARCHITECT CEA PACKAGE INSERT WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE. INFORMATION FROM THE SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS AND THE LIMITATIONS OF PROCEDURE SECTIONS OF THE PACKAGE INSERT WERE COMMUNICATED TO THE CUSTOMER TO ASSIST THEM IN THEIR EVALUATION OF PATIENT RESULTS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY.
Description of Event or Problem
THE ACCOUNT STATED THAT AN ARCHITECT CEA RESULT OF <0.5 NG/ML WAS GENERATED ON A PATIENT WITH CANCER. THE PHYSICIAN QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED X4 WITH THE FOLLOWING RESULTS: 32.01 NG/ML, 33.35 NG/ML, 31.82 NG/ML, AND 32.41 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.