ARCHITECT TACROLIMUS

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. AN EVALUATION IS IN-PROCESS.

Description of Event or Problem

THE CUSTOMER OBSERVED ONE PATIENT WITH A FALSELY ELEVATED TACROLIMUS RESULT WHILE USING THE ARCHITECT TACROLIMUS ASSAY. THE RESULTS WERE GENERATED DURING TREATMENT FOR A PATIENT UNDERGOING ACUTE REJECTION FOR A HEART TRANSPLANT (RECEIVED (B)(6) 2016). THE CUSTOMER INDICATED THAT 2 CONSECUTIVE VALUES WHICH HAD BEEN DRAWN ON (B)(6) 2017 SHOWED A FALSELY ELEVATED, AS FOLLOWS: ON (B)(6) 2017: 11.2 MG/DL. ON (B)(6) 2017: 44.2 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

UPDATES: ADDITIONAL TEST RESULT DATA WAS PROVIDED BY THE CUSTOMER. LOT NUMBER HAS BEEN PROVIDED. CONCOMITANT MEDICAL PRODUCT: SERIAL NUMBER CORRECTED TO (B)(4). INVESTIGATION: INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, AN INSTRUMENT LOG REVIEW, IN-HOUSE TESTING, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. RETURN MATERIAL WAS NOT AVAILABLE FROM THE CUSTOMER. THE CUSTOMER PERFORMED A CORRELATION STUDY WITH THE ARCHITECT I2000SR AND A LABORATORY USING A MASS SPECTROPHOTOMETER TACROLIMUS ASSAY, AND SIMILAR RESULTS WERE OBTAINED. THE CUSTOMER INDICATED THAT THE ISSUE WITH ELEVATED TACROLIMUS RESULTS IS BELIEVED TO BE SOLELY PATIENT/METABOLIC RELATED AND NOT A TACROLIMUS TEST OR ANALYZER ISSUE. AN INSTRUMENT LOG REVIEW WAS COMPLETED AND DID NOT IDENTIFY CONCLUSIVE INFORMATION TO INDICATE AN INSTRUMENT OR SAMPLE INTEGRITY ISSUE OCCURRED. AT THE TIME THE ELEVATED TACROLIMUS RESULT WAS GENERATED THE QUALITY CONTROL AND CALIBRATION VALUES WERE WITHIN ACCEPTANCE RANGES. ELEVATED TACROLIMUS RESULTS WERE NOT GENERATED WITH ANY OTHER PATIENT SPECIMENS. AN ACCURACY TESTING PROTOCOL WAS EXECUTED TO EVALUATE THE PERFORMANCE OF REAGENT LOT 72006M800; AN INTERNAL PANEL WAS TESTED WITH RETAINED KITS OF THE LIKELY CAUSE REAGENT LOT. TESTING MET THE ACCEPTANCE CRITERIA AND DETERMINED THE REAGENT IS PERFORMING ACCEPTABLY. TRACKING AND TRENDING DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO FALSELY ELEVATED RESULTS FOR THE LOT IN QUESTION. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY OF THE ARCHITECT TACROLIMUS REAGENT, LIST 01L77, LOT 72006M800, WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER PROVIDED ADDITIONAL ARCHITECT TACROLIMUS RESULTS FOR THE SAME PATIENT COMPARED TO RESULTS GENERATED AT ANOTHER LABORATORY USING A MASS SPECTROPHOTOMETER TACROLIMUS ASSAY. (B)(6) 2017: ARCHITECT TACROLIMUS: 12.0, MASS SPEC: 14.3; (B)(6) 2017: ARCHITECT TACROLIMUS: >60, MASS SPEC: >80; (B)(6) 2017: ARCHITECT TACROLIMUS: >60, MASS SPEC: 61.8; (B)(6) 2017: ARCHITECT TACROLIMUS: 77.1, MASS SPEC: 64.8; (B)(6) 2017: ARCHITECT TACROLIMUS: 11.8, MASS SPEC: SPECIMEN NOT AVAILABLE; (B)(6) 2017: ARCHITECT TACROLIMUS: 27.6, MASS SPEC: SPECIMEN NOT AVAILABLE; (B)(6) 2017: ARCHITECT TACROLIMUS: 26.9, MASS SPEC: 21.6; (B)(6) 2017: ARCHITECT TACROLIMUS: 4.9, MASS SPEC: 4.6; (B)(6) 2017: ARCHITECT TACROLIMUS: 8.4, MASS SPEC: 8.5.