THE ACCOUNT NOTICED IMPRECISION OF PATIENT RESULTS AND CONTROL VALUES OUT OF RANGE DUE TO THE IMPRECISION OF ARCHITECT CYCLOSPORINE. THE ACCOUNT STATED THE %CV IS 11-12%. THE ACCOUNT PROVIDED ARCHITECT CYCLOSPORINE RESULTS FOR ONE PATIENT. A PATIENT SAMPLE GENERATED ARCHITECT CYCLOSPORINE RESULTS OF 119 AND 149 NG/ML. THE SAME SAMPLE PREPARATION WAS RERUN WITH ARCHITECT CYCLOSPORINE OF 202 AND 181 NG/ML. A NEW SAMPLE PREPARATION WAS MADE AND GENERATED ARCHITECT CYCLOSPORINE RESULTS OF 162 AND 219 NG/ML. THE SECOND SAMPLE PREPARATION WAS RERUN ON ANOTHER ARCHITECT I2000 RESULTING IN 167 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
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Patient 1
THE CUSTOMER INDICATED THEY WERE USING LOT NUMBERS 11075M500, 10030M500, 13088M500, 13089M500, 14604M500, 16115M500, 16116M500, DURING THE TIMEFRAME OF THIS EVENT. IT IS UNKNOWN WHICH LOT GENERATED THE DISCREPANT RESULTS. LOT 11075M500: DATE OF MANUFACTURE = JANUARY 2012; DEVICE EXPIRATION DATE = 23JUN2012 LOT 10030M500: DATE OF MANUFACTURE = JANUARY 2012; DEVICE EXPIRATION DATE = 27NOV2012 LOT 13088M500: DATE OF MANUFACTURE = APRIL 2012; DEVICE EXPIRATION DATE = 02FEB2013 LOT 13089M500: DATE OF MANUFACTURE = MARCH 2012; DEVICE EXPIRATION DATE = 01FEB2013 LOT 14604M500: DATE OF MANUFACTURE = JUNE 2012; DEVICE EXPIRATION DATE = 09MAY2013 LOT 16115M500: DATE OF MANUFACTURE = JULY 2012; DEVICE EXPIRATION DATE = 09MAY2013 LOT 16116M500: DATE OF MANUFACTURE = AUGUST 2012; DEVICE EXPIRATION DATE = 10MAY2013 (B)(4). INVESTIGATIONS WERE CONDUCTED TO FIND THE PROBABLE CAUSE OF THE ARCHITECT CYCLOSPORINE ASSAY DISCREPANT PATIENT RESULTS. IT WAS CONCLUDED THAT THE MOST PROBABLE CAUSE WAS A REACTION VESSEL (RV) RESIN CHANGE SOURCED FROM A NEW VENDOR. WHEN THE CUSTOMER MIXED REACTION VESSELS FROM BOTH RESIN LOTS FOR ASSAY CALIBRATION AND/OR ASSAY TEST RUNS, AN INCREASE IN DISCREPANT RESULTS WAS SEEN ALONG WITH CALIBRATION FAILURES AND CONTROLS SHIFTING AND/OR READING OUT OF SPECIFICATIONS. IT WAS FOUND THAT THERE IS GREATER ADHERENCE OF THE CYCLOSPORINE/MICROPARTICLE-CYCLOSPORINE COMPLEX TO THE RV WALL FOR RVS MADE USING THE RESIN FROM THE NEW VENDOR VERSUS THE RESIN RVS FROM THE FORMER VENDOR. THE INVESTIGATION ALSO FOUND THAT THE RESIN RV LOT TO LOT VARIABILITY OF THE NEW VENDOR IS NOT CAUSING ASSAY PERFORMANCE ISSUES AND THAT THE RESIN CHANGE DID NOT CAUSE SAMPLE CONCENTRATION SHIFTS IN CUSTOMER DATA. CUSTOMERS HAD BEEN INFORMED BY PRODUCT CORRECTION LETTER FA07OCT2011 TO ONLY USE RV LOTS MANUFACTURED WITH THE SAME RESIN FOR THE ARCHITECT CYCLOSPORINE ASSAY. IF THESE INSTRUCTIONS ARE FOLLOWED, ASSAY PRECISION IS RESTORED TO WITHIN PACKAGE INSERT CLAIMS. PER CURRENT PRODUCT AVAILABILITY, ONLY THE NEW VENDOR RESIN IS NOW BEING MANUFACTURED AND USED EXCLUSIVELY FOR REACTION VESSEL PRODUCTION. SINCE USING THE REACTION VESSELS MANUFACTURED WITH THE NEW RESIN FORMULATION, THE CALIBRATION CURVE IS SLIGHTLY FLATTER, WHICH RESULTS IN HIGHER %CVS THAN PREVIOUSLY OBSERVED WITH THE ASSAY, BUT STILL WITHIN PRECISION CLAIM OF < 15 %. THE ARCHITECT CYCLOSPORINE ASSAY WILL BE INCLUDED IN FUTURE TESTING OF ANY RESIN CHANGES. IMPROVEMENT EFFORTS ARE ONGOING AND PLANNED TO BE FINALIZED FOURTH QUARTER 2013.