ARCHITECT CA19-9XR REAGENT KIT

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION 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. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. A SEARCH FOR SIMILAR COMPLAINTS DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 62081FP00. 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 NUMBER 62081FP00 AND THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. THE OVERALL PERFORMANCE OF THE ARCHITECT CA 19-9XR REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE PATIENT MEDIAN VALUES OBTAINED WITH THE COMPLAINT LOT 62081FP00 IS WITHIN ESTABLISHED LIMITS AND THUS COMPARABLE TO THE HISTORICAL LOT PERFORMANCE, WHICH CONFIRMS NO SYSTEMIC ISSUE FOR THE LOT. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT CA 19-9XR REAGENT LOT 62081FP00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED DISCREPANT ARCHITECT CA19-9XR RESULTS FOR A 81-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2024, SID (B)(6), INITIAL RESULT = 18.37 IU/ML. ON (B)(6) 2024, SID (B)(6), INITIAL RESULT = 70.64 IU/ML. CLINICAL DETAILS OF THE PATIENT: DERANGED LFTS IT IS UNKNOWN IF THE PATIENT HAS BEEN DIAGNOSED WITH PANCREATIC CANCER. THE CUSTOMER IS UNSURE OF WHICH RESULT IS CORRECT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Description of Event or Problem

THE CUSTOMER OBSERVED DISCREPANT ARCHITECT CA19-9XR RESULTS FOR A 81-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2024 SID (B)(6) INITIAL RESULT = 18.37 IU/ML. ON (B)(6) 2024 SID (B)(6) INITIAL RESULT = 70.64 IU/ML. CLINICAL DETAILS OF THE PATIENT: DERANGED LFTS IT IS UNKNOWN IF THE PATIENT HAS BEEN DIAGNOSED WITH PANCREATIC CANCER. THE CUSTOMER IS UNSURE OF WHICH RESULT IS CORRECT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

COMPLETED INFORMATION FOR SECTION A1 PATIENT IDENTIFIER: SIDS (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 2K91-32 HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2K91-33.