ARCHITECT CEA
Received Sep 7, 2012 · Event occurred Aug 17, 2012
Report 1415939-2012-01993 · MDR key 2735840
Device
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE ACCOUNT GENERATED INCONSISTENT ARCHITECT CEA RESULTS ON A PATIENT SPECIMEN. THE PATIENT SPECIMEN WAS TESTED SEVERAL TIMES WITH ARCHITECT CEA WITH RESULTS OF 10, 0.9, 10, 0.8 NG/ML. THE CORRECT OR EXPECTED CEA RESULT FOR THE PATIENT IS UNKNOWN. NO PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
A REVIEW OF COMPLAINTS DID NOT IDENTIFY ANY ISSUES OR ADVERSE TRENDS FOR REAGENT LOT 17268LF00 OR FOR THE CUSTOMER'S ISSUE. TESTING OF TWO SERUM BASED SAMPLES WITH A RETAINED KIT OF ARCHITECT CEA REAGENT 7K68-22, LOT 17268LF00 MET ACCEPTANCE SPECIFICATIONS. A REVIEW OF MANUFACTURING RECORDS AND TESTING DATA GENERATED PRIOR TO APPROVAL OF THIS REAGENT LOT DID NOT IDENTIFY ANY ISSUES. LABELING WAS REVIEWED AND CONTAINS ADEQUATE INFORMATION REGARDING SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS. THIS INVESTIGATION INDICATES THAT THE ARCHITECT CEA REAGENT 7K68-22, LOT 17268LF00 IS PERFORMING AS INTENDED. NO PRODUCT DEFICIENCY WAS IDENTIFIED. THE ISSUE SEEN APPEARS TO BE FOR A DISCRETE SAMPLE INDICATING A SAMPLE SPECIFIC OR HANDLING ISSUE.
Additional Manufacturer Narrative
THIS REPORT IS BEING FILED ON INTERNATIONAL PRODUCT, ARCHITECT CEA, LIST 7K68, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE U.S., ARCHITECT CEA, LIST 6C02. (B)(4). A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. EVALUATION IN PROGRESS