ARCHITECT CA19-9XR REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT CA 19-9XR RESULT FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT = AROUND 40 U/ML RESULT LAST YEAR = 2000 U/ML (NO CHANGE DESPITE RETEST), REPEAT RESULT AT ANOTHER LABORATORY = AROUND 40 U/ML PAST HISTORICAL RESULTS = AROUND 40 U/ML IT IS UNKNOWN IF THE PATIENT HAS BEEN DIAGNOSED WITH PANCREATIC CANCER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FINAL 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 2K91-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2K91-33.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, 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. TICKET TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY POTENTIAL NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE LIKELY CAUSE LIST NUMBER AND COMPLAINT ISSUE. THE PATIENT¿S DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT, WHICH INDICATED THAT THE PATIENT MEDIAN RESULT FOR ALL THE ARCHITECT CA 19-9XR LOTS IS WITHIN THE ESTABLISHED CONTROL LIMITS. THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED FOR ARCHITECT CA 19-9XR LOTS. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT CA 19-9XR ASSAY, FOR UNKNOWN LOT NUMBER, WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT CA 19-9XR RESULT FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT = AROUND 40 U/ML RESULT LAST YEAR = 2000 U/ML (NO CHANGE DESPITE RETEST), REPEAT RESULT AT ANOTHER LABORATORY = AROUND 40 U/ML. PAST HISTORICAL RESULTS = AROUND 40 U/ML. IT IS UNKNOWN IF THE PATIENT HAS BEEN DIAGNOSED WITH PANCREATIC CANCER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.