ARCHITECT CEA
Received Apr 12, 2018 · Event occurred Jan 2, 2018
Report 3008344661-2018-00030 · MDR key 7426437
Device
Generic name
Carcinoembryonic Antigen
Manufacturer
Abbott IrelandCatalog number
07K68-35
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
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. AN EVALUATION IS IN-PROCESS.
Description of Event or Problem
THE CUSTOMER OBSERVED ERRATIC RESULTS WHILE USING THE ARCHITECT CEA ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS DATA: ON (B)(6) 2018 CEA INITIAL 0.5, RETEST 4.4 NG/ML THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED. NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE.
Additional Manufacturer Narrative
EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, FIELD DATA REVIEW, A DESIGN HISTORY RECORD (DHR) REVIEW, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. RETURN MATERIAL WAS NOT AVAILABLE. AN ANALYSIS UTILIZING CUSTOMER FIELD DATA WAS USED TO ASSESS THE SPECIFICITY OF THE ASSAY. INSTRUMENT DATA ANALYTICS (IDA) REPORTS FOR LIST THE ARCHITECT CEA ASSAY WERE REVIEWED TO DETERMINE IF THE MEDIAN PATIENT VALUES HAVE SHIFTED OVER TIME. THE ANALYSIS CONCLUDED THAT ALL REAGENT LOTS READ PATIENT RESULTS CONSISTENTLY THEREFORE DETERMINED THE REAGENT IS PERFORMING ACCEPTABLY. THE DHR REVIEW DID NOT IDENTIFY ANY POTENTIAL NON-CONFORMANCES, NON-CONFORMANCES OR DEVIATIONS RELATED TO THE COMPLAINT ISSUE. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY OF THE ARCHITECT CEA REAGENT, LIST NUMBER 07K68, WAS IDENTIFIED.