ARCHITECT CEA REAGENT KIT
Received Dec 17, 2021 · Event occurred Dec 1, 2021
Report 3008344661-2021-00214 · MDR key 13028546
Device
Generic name
System, Test, Carcinoembryonic Antigen
Manufacturer
Abbott IrelandModel number
07K68-35Catalog number
07K68-35
Lot number
26470FN00
Product problems
- Low Test Results
- Low Test Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COMPLAINT INVESTIGATION FOR FALSELY DEPRESSED ARCHITECT CEA RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND FIELD DATA REVIEW. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH LOT 26470FN00 AND THE COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF ARCHITECT CEA WAS REVIEWED USING FIELD DATA FROM CUSTOMERS WORLDWIDE. THE MEDIAN PATIENT POPULATION RESULT FOR LOT 26470FN00 IS COMPARABLE WITH ALL OTHER LOTS IN THE FIELD AND CONFIRMS NO SYSTEMIC ISSUE FOR THE LOT. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ARCHITECT CEA REAGENT FOR LOT 26470FN00 WAS IDENTIFIED.
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT CEA (CARCINOEMBRYONIC ANTIGEN) RESULTS FOR A 67 YEAR OLD MALE DIAGNOSED WITH DIGESTION VISCERAL CANCER. THE FOLLOWING DATA WAS PROVIDED: 01DEC2021 SID (B)(6) INITIAL RESULT WAS >1500 NG/ML, REPEAT = 9.7 NG/ML, REPEAT WITH A DILUTION = 2114.7 NG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
COMPLETED INFORMATION FOR PATIENT IDENTIFIER: (B)(6). 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 ARCHITECT CEA (CARCINOEMBRYONIC ANTIGEN) RESULTS FOR A (B)(6) MALE DIAGNOSED WITH DIGESTION VISCERAL CANCER. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2021, SID (B)(6), INITIAL RESULT WAS >1500 NG/ML, REPEAT = 9.7 NG/ML, REPEAT WITH A DILUTION = 2114.7 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.