ARCHITECT CEA
Received Jan 8, 2019
Report 3008344661-2019-00004 · MDR key 8225989
Device
Generic name
Carcinoembryonic Antigen
Manufacturer
Abbott IrelandCatalog number
07K68-27
Lot number
88126FN00
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
FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, REVIEW OF FIELD DATA, AND A REVIEW OF LABELING. A COMPLAINT TRENDING REVIEW DETERMINED NO ADVERSE TREND, NONCONFORMANCES, OR POTENTIAL NONCONFORMANCES WERE IDENTIFIED FOR THE CUSTOMER ISSUE. REVIEW OF DATA DETERMINED THAT THE PATIENT MEDIAN RESULT FOR THE LIKELY CAUSE PRODUCT LOT IS COMPARABLE WITH OTHER LOTS IN THE FIELD AND NO SYSTEMIC ISSUE WAS IDENTIFIED. A REVIEW OF THE PRODUCT QUALITY HISTORY FOR THE LOT NUMBER DID NOT IDENTIFY ISSUES ASSOCIATED WITH THE CUSTOMER OBSERVATION. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. NO RETURN PATIENT SAMPLE WAS AVAILABLE. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS COMPLAINT INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.
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 REPORTED FALSE DECREASED ARCHITECT CEA RESULT FOR A RECENTLY DIAGNOSED COLON CANCER PATIENT. THE FOLLOWING CEA RESULTS WERE PROVIDED: 10/18: 6.6 NG/ML; 12/4: 4.8 NG/ML. THE CUSTOMER REPORTS NO TREATMENT WAS DONE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.