ARCHITECT CA19-9XR

Additional Manufacturer Narrative

SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 02K91-78 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 02K91-33, WITH 510K/PMA/BLA NUMBER K052000. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER REPORTED THAT A FALSELY ELEVATED ARCHITECT CA 19-9XR RESULT WAS GENERATED BY THE ARCHITECT I2000SR PROCESSING MODULE FOR A PATIENT SAMPLE. IT IS UNKNOWN WHETHER THE PATIENT HAS BEEN DIAGNOSED WITH PANCREATIC CANCER. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S REFERENCE RANGE: 0 TO 35 U/ML SID (B)(6): INITIAL RESULT = 76 U/ML (B)(6), REPEAT RESULT = 110 U/ML (B)(6). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Description of Event or Problem

THE CUSTOMER REPORTED THAT A FALSELY ELEVATED ARCHITECT CA 19-9XR RESULT WAS GENERATED BY THE ARCHITECT I2000SR PROCESSING MODULE FOR A PATIENT SAMPLE. IT IS UNKNOWN WHETHER THE PATIENT HAS BEEN DIAGNOSED WITH PANCREATIC CANCER. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S REFERENCE RANGE: 0 TO 35 U/ML SID (B)(6): INITIAL RESULT = 76 U/ML (B)(6), REPEAT RESULT = 110 U/ML (B)(6) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED ARCHITECT CA 19-9XR RESULTS 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 IN-HOUSE TESTING OF A RETAINED KIT OF THE COMPLAINT LOT NUMBER. TRENDING REVIEW DETERMINED NO RELATED TREND FOR THE ISSUE FOR THE PRODUCT. ACCURACY TESTING WAS PERFORMED USING AN IN-HOUSE RETAINED KIT OF LOT 78762FP00, STORED AT THE RECOMMENDED STORAGE CONDITION. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LOT AND COMPLAINT ISSUE. MANUFACTURING DOCUMENTATION FOR THE LOT WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INFORMATION PROVIDED AND ABBOTT DIAGNOSTICS¿ COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF ARCHITECT CA 19-9XR REAGENT, LOT NUMBER 78762FP00 WAS IDENTIFIED.