AXSYM CEA
Received Mar 10, 2011
Report 1415939-2011-00065 · MDR key 2013166
Device
Generic name
Quantitative Measurement Of Carcinoembryonic Antigen (cea)
Manufacturer
Abbott LaboratoriesCatalog number
3K47-20
Lot number
92117Q100
Product problems
- Low Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
Additional Manufacturer Narrative
(B)(4). FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, IN-HOUSE TESTING, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. AN ACCURACY EVALUATION WAS PERFORMED WITH FILE KIT MATERIAL OF LOT 92117Q100 AND USING A CEA PANEL. THE TESTING MET THE ACCURACY REQUIREMENTS WHICH INDICATED THAT THE LOT WAS PERFORMING AS EXPECTED. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.
Description of Event or Problem
THE CUSTOMER STATES THAT A PATIENT SAMPLE PROCESSED USING THE AXSYM CEA ASSAY GENERATED A POTENTIALLY FALSELY LOW RESULT OF 6.3 NG/ML. THE SAMPLE YIELDED REPRODUCIBLE HIGHER RESULTS WHEN TESTED USING ALTERNATE METHODS; ARCHITECT CEA: 50.8 NG/ML AND ROCHE MODULAR: 52.4 NG/ML. NO ADVERSE OUTCOMES WERE REPORTED RELATED TO THIS ISSUE.