ARCHITECT CEA
Received Dec 4, 2018 · Event occurred Oct 19, 2018
Report 3008344661-2018-00101 · MDR key 8131062
Device
Generic name
Carcinoembryonic Antigen
Manufacturer
Abbott IrelandCatalog number
07K68-25
Lot number
UNKNOWN
Product problems
- Low Test Results
- Low Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A REVIEW OF TICKETS DETERMINED NORMAL COMPLAINT ACTIVITY FOR THE ARCHITECT CEA ASSAY AND THERE WERE NO TRENDS IDENTIFIED FOR THE PRODUCT ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. HISTORICAL PERFORMANCE IN THE FIELD OF ARCHITECT CEA REAGENT LOTS USING WORLD WIDE DATA THROUGH ABBOTTLINK WAS EVALUATED. THE REVIEW SHOWS THAT THE MEDIAN VALUES FOR ALL CEA LOTS ARE WITHIN +/-3SD OF THE OVERALL MEDIAN INDICATING THAT ALL LOTS ARE COMPARABLE AND PERFORMING ACCEPTABLY IN THE FIELD. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER'S OBSERVATION. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS ADEQUATELY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT CEA ASSAY, LIST NUMBER 07K68-25.
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY DEPRESSED RESULTS WHILE USING ARCHITECT CEA (CARCINOEMBRYONIC ANTIGEN) REAGENTS. THE FOLLOWING DATA WAS PROVIDED FOR THE SAME PATIENT. TESTED (B)(6) 2018 5.9 NG/ML. PREVIOUS AND SUBSEQUENT RESULTS WERE HIGHER WHEN TESTED ON (B)(6) 2018 (302.5 NG/ML) AND (B)(6) 2018 (430.8 NG/ML). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.