| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ARCHITECT CYCLOSPORINE | ABBOTT LABORATORIES | MKW | 01L75-25 | 18062M500 | Y | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-03-01 | 0 |
Patient 1
THE CUSTOMER REPORTS A FALSELY DECREASED RESULT GENERATED FOR ONE PATIENT SAMPLE TESTED WITH THE ARCHITECT CYCLOSPORINE ASSAY. AN INITIAL RESULT OF 20 NG/ML WAS OBTAINED. THE FOLLOWING DAY THE SAMPLE WAS RETESTED AND GENERATED RESULTS OF 211 AND 232 NG/ML. NO SUSPECT RESULT HAVE BEEN REPORTED FROM THE LAB. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED. THE CUSTOMER REQUESTED A SERVICE CALL THAT FOUND NO INSTRUMENT ISSUES.
Patient 1
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).
Patient 1
A PRODUCT DEFICIENCY HAS BEEN IDENTIFIED AND AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. THE CUSTOMER IDENTIFIED THE INITIAL RESULT AS SAMPLE IDENTIFICATION NUMBER 15708. THE SUBSEQUENT RETESTS WERE IDENTIFIED AS SAMPLE IDENTIFICATION NUMBERS 15738 AND 15739 RESPECTIVELY.
Patient 1
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 (B)(4) 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 LESS THAN 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.
Patient 1
UPON FURTHER REVIEW IT WAS DECIDED THAT THE CUSTOMER ISSUE OF DISCREPANT ARCHITECT CYCLOSPORINE ASSAY RESULTS REPORTED IN THIS COMPLAINT IS NOT ASSOCIATED WITH THE DEFICIENCY DOCUMENTED AS THE MOST PROBABLE CAUSE OF A CHANGE IN RESIN TO THE ARCHITECT REACTION VESSEL (RV) SOURCED FROM A NEW VENDOR AND HAS BEEN UNASSIGNED TO THESE ACTIONS. AN UPDATED PRODUCT EVALUATION FOLLOWS: A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. NO ATYPICAL COMPLAINT ACTIVITY WAS IDENTIFIED. SINCE REAGENT LOT 18062M500 IS EXPIRED, TESTING WITH THIS REAGENT LOT COULD NOT BE PERFORMED. HOWEVER, ACCURACY TESTING WITH AN ALTERNATE REAGENT LOT WAS REVIEWED AS REPRESENTATIVE DATA FOR THE ASSAY. THE TESTING WAS COMPLETED USING RETAINED KITS OF REAGENT LOT 18265M500 USING TWO INTERNAL CYCLOSPORINE PANELS. ACCEPTANCE CRITERIA WAS MET, WHICH INDICATES ACCEPTABLE PRODUCT PERFORMANCE. THE ARCHITECT CYCLOSPORINE ASSAY PACKAGE INSERT CONTAINS INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. BASED ON THE RESULTS OF THE CURRENT EVALUATION, A PRODUCT MALFUNCTION WAS NOT IDENTIFIED.