ARCHITECT CA19-9XR

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, A TICKET TRENDING REVIEW, A DEVICE HISTORY RECORD REVIEW, A FIELD DATA REVIEW, AND A LABELING REVIEW. THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT CA 19-9XR ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 74577FP00. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH LOT 74577FP00 AND THE COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF ARCHITECT CA 19-9XR REAGENTS WAS REVIEWED USING FIELD DATA 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 74577FP00 IS WITHIN THE ESTABLISHED CONTROL LIMITS. THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED FOR 74577FP00. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ARCHITECT CA 19-9XR REAGENT, LOT NUMBER 74577FP00.

Description of Event or Problem

THE CUSTOMER OBSERVED ERRATIC ARCHITECT CA 19-9XR FOR TWO PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE < = 37 U/ML): SID (B)(6), INITIAL CA 19-9 RESULT= 11.49 U/ML; REPEAT RESULT= 2.75 U/ML, 3.39 U/ML. SID (B)(6), INITIAL CA 19-9 RESULT= 16.98 U/ML; REPEAT RESULT = <2 U/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Description of Event or Problem

THE CUSTOMER OBSERVED ERRATIC ARCHITECT CA 19-9XR FOR TWO PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE < = 37 U/ML): SID (B)(6), INITIAL CA 19-9 RESULT= 11.49 U/ML; REPEAT RESULT= 2.75 U/ML, 3.39 U/ML. SID (B)(6), INITIAL CA 19-9 RESULT= 16.98 U/ML; REPEAT RESULT = <2 U/ML . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

COMPLETE ENTRY FOR SECTION A1 - PATIENT IDENTIFIER: (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. 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, CA 19-9 XR, WITH 510K NUMBER K052000.