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, LABELLING REVIEW, DEVICE HISTORY RECORD REVIEW, AND INHOUSE TESTING OF A RETAINED KIT WITH THE COMPLAINT LOT NUMBER. TRENDING REVIEW DETERMINED NO TRENDS FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LIKELY CAUSE LOT. INHOUSE TESTING DETERMINED THAT THE ACCURACY PERFORMANCE IS NOT NEGATIVELY IMPACTED. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON OUR INVESTIGATION, WE HAVE DETERMINED THAT THERE IS NO SYSTEMIC ISSUE AND/OR PRODUCT DEFICIENCY WITH ARCHITECT CA 19-9XR REAGENT LOT 68327FP00. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT CA 19-9XR RESULT ON A PATIENT. RESULTS PROVIDED: ARCHITECT = >1200 U/ML / AUTO-DILUTE = 400 U/ML; MANUAL DILUTION X5 = 500 U/ML. PREVIOUS VALUE = 400 U/ML. IT IS UNKNOWN IF THE PATIENT HAS BEEN DIAGNOSED WITH PANCREATIC CANCER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.