ARCHITECT CA19-9XR REAGENT KIT

Additional Manufacturer Narrative

THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 02K91-39 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2K91-33 WITH 510K/PMA/BLA NUMBER K052000. THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, 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. DEVICE HISTORY REVIEW FOR THE COMPLAINT LOT DID NOT IDENTIFY ANY ISSUES. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY AN INCREASE IN COMPLAINTS FOR THE ARCHITECT CA 19-9XR REAGENT AND DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE COMPLAINT LOT. THE OVERALL PERFORMANCE OF THE ARCHITECT CA 19-9XR REAGENT REVIEWED USING FIELD DATA FROM CUSTOMERS. THE REVIEW OF FIELD DATA DETERMINED THE MEDIAN PATIENT RESULTS FOR LOT 69360FP00 WAS WITHIN THE ESTABLISHED LIMITS. LABELING WAS REVIEWED AND WAS FOUND TO ADDRESS THE CUSTOMER REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT CA 19-9XR REAGENT LOT 69360FP00.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT CA19-9XR AND PROVIDED THE FOLLOWING DATA FOR 1 PATIENT: SAMPLE ID (B)(6) INITIAL RESULT WAS 188.88 U/ML (REFERENCE RANGE < 37 U/ML). THE SAMPLE WAS REPEATED AND GENERATED A RESULT OF 46.45 U/ML. WHEN REPEATED ON ANOTHER ANALYZER, THE RESULT WAS 46.73 U/ML. AFTER PERFORMING SOME TROUBLESHOOTING, THE SAMPLE WAS REPEATED ON THE ORIGINAL ANALYZER 3 TIMES AND GENERATED RESULTS OF 47.09, 46.76, AND 45.96 U/ML. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.