ARCHITECT CA19-9XR

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT CA 19-9XR RESULTS FOR AN 87-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF PANCREATIC DUCTAL CARCINOMA. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6) RESULT, (B)(6) 2025 WITH REAGENT LOT NUMBER 76657FP00, WAS 66.41 U/ML RESULTS GENERATED WITH REAGENT LOT NUMBER 79760FP00: SAMPLE ID (B)(6) INITIAL RESULT, ON (B)(6) 2026, WAS 1200.00, REPEAT RESULT, WITH AUTO-DILUTION, WAS 1326.64 U/ML SAMPLE ID (B)(6) INITIAL RESULT, ON (B)(6) 2026, WAS 167.28, REPEAT RESULT WAS 166.07 U/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT CA 19-9XR RESULTS FOR AN 87-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF PANCREATIC DUCTAL CARCINOMA. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6) RESULT, ON (B)(6) 2025 WITH REAGENT LOT NUMBER 76657FP00, WAS 66.41 U/ML RESULTS GENERATED WITH REAGENT LOT NUMBER 79760FP00: SAMPLE ID (B)(6) INITIAL RESULT, ON (B)(6) 2026, WAS >1200.00, REPEAT RESULT, WITH AUTO-DILUTION, WAS 1326.64 U/ML. SAMPLE ID (B)(6) INITIAL RESULT, ON (B)(6) 2026, WAS 167.28, REPEAT RESULT WAS 166.07 U/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 02K91-32, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 02K91-33, AND A 510K NUMBER OF K052000. THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED ARCHITECT CA 19-9XR 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 IN-HOUSE TESTING OF A RETAINED KIT OF A COMPLAINT LOT NUMBER. A REVIEW OF TRACKING AND TRENDING FOR THE PRODUCT AND THE LOTS DID NOT IDENTIFY A TREND. THE OVERALL PERFORMANCE OF ARCHITECT CA 19-9XR REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE PATIENT¿S DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS EVALUATION INDICATED THAT THE PATIENT MEDIAN RESULT FOR LOT 76657FP00 IS WITHIN THE ESTABLISHED CONTROL LIMITS. THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED FOR THE LOT 76657FP00. HOWEVER, REVIEW OF THE DATA ASSOCIATED WITH REAGENT LOT 79760FP00 INDICATES THE PATIENT MEDIAN EXCEEDED THE ESTABLISHED LIMITS FOR ARCHITECT CA 19-9XR. ADDITIONAL ACCURACY TESTING WAS CONDUCTED FOR THE LOT 79760FP00. ACCURACY TESTING WAS PERFORMED USING AN IN-HOUSE RETAINED KIT OF LOT 79760FP00, STORED AT THE RECOMMENDED STORAGE CONDITION. ALL SPECIFICATIONS WERE MET, INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LOTS AND COMPLAINT ISSUE. MANUFACTURING DOCUMENTATION FOR THE LOTS WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INFORMATION PROVIDED AND ABBOTT DIAGNOSTICS¿ COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF ARCHITECT CA 19-9XR REAGENT, LOT NUMBERS 76657FP00 AND 79760FP0, WAS IDENTIFIED.