ABBOTT AXSYM SYSTEM

Description of Event or Problem

THE CUSTOMER STATES THAT IN 2005, ONE PT GENERATED AN AXSYM TO XOPLASMOSIS IGM ASSAY INDEX RESULT OF 1.04 (REACTIVE). THE AXSYM TOXOPLASMOSIS IGG ASSAY RESULT FOR THIS PT WAS REACTIVE AT 19 IU/ML. A NEW SAMPLE WAS DRAWN 16 DAYS LATER, AND GENERATED A REACTIVE AXSYM TOXO IGM ASSAY RESULT OF 0.94. THE SAMPLES WERE SENT TO A FOLLOW-UP CTR LAB FOR TESTING AND GENERATED NON-REACTIVE RESULTS. THE MOST RECENT SAMPLE WAS ALSO SENT TO ANOTHER TESTING LABORATORY AND GENERATED A NON-REACTIVE RESULT FOR TOXO IGM. CONTROLS WERE WITHIN SPECIFICATIONS ON ALL RUNS. A REVIEW OF THE AXSYM'S MESSAGE HISTORY LOG FOUND A NUMBER OF HARDWARE ERRORS OCCURRING AROUND THE SAME TIME AS THE TESTING OF BOTH SAMPLES. A FIELD SERVICE TECHNICAL EXECUTIVE (TE) WAS SENT TO THE CUSTOMER SITE. THERE IS NO IMPACT TO PT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

THE FIELD SERVICE TECHNICAL EXECUTIVE (TE) WAS DISPATCHED TO RESOLVE THE HARDWARE ISSUES AND TO PROVIDE CUSTOMER TRAINING. THE TE REPLACED THE MUP PUMP (#3) AS THERE WAS CRYSTALLIZATION ON THE PUMP. AFTERWARDS, THE PUMP AND VOLUME CHECKS AS WELL AS THE MUP/BACKGROUND CHECKS WERE WITHIN SPECIFICATION. BOTH PROBES WERE CALIBRATED, THE TUBINGS WERE CHECKED AND NO BUBBLES WERE FOUND. CONTROLS WERE RUN AND WERE WITHIN SPECIFICATIONS AND NO FURTHER ISSUES WERE DOCUMENTED. DAILY AND WEEKLY MAINTENANCE REQUIRES THE OPERATOR TO CHECK FOR DIRT/DAMAGE TO THE PROBE AND TO FLUSH AND PRIME THE PUMPS AND SYRINGES. IT WAS ALSO LEARNED THE PT SAMPLES ARE NOT BEING CENTRIFUGED PER PACKAGE INSERT INSTRUCTIONS. THE MOST PROBABLE CAUSE FOR THE INCONSISTENT RESULTS WAS THE PUMP AND SPECIMEN INTEGRITY. THE ACTUAL CAUSE COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. THIS ISSUE IS COVERED IN THE LAVELING OF THE SYSTEM. MULTIPLE PROBABLE CAUSES AND CORRECTIVE ACTIONS ARE LISTED FOR AN INCONSISTENT RESULT. IN CONCLUSION, NO SYSTEMIC ISSUES WERE IDENTIFIED INDICATING THAT THE PRODUCT IS PERFORMING OUTSIDE OF LABELING CLAIMS. THERE WAS NO DEFICIENCY FOUND CONCERNING THE AXSYM SYSTEM THAT WOULD SUGGEST THAT THE USE OF THIS PRODUCT WOULD CAUSE SOME TYPE OF ADVERSE HEALTH CONSEQUENCES OR THAT THE PRODUCT IS PERFORMING CONTRARY TO INTENDED USE OR LABEL CLAIMS. THIS IS A FINAL REPORT.