ADVIA CENTAUR XP

Description of Event or Problem

A DISCORDANT, FALSELY LOW PROSTATE SPECIFIC ANTIGEN (PSA) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON AN ADVIA CENTAUR XP INSTRUMENT. ADDITIONALLY DISCORDANT, FALSELY LOW CANCER ANTIGEN 15-3 (CA 15-3) AND CARCINOEMBRYONIC ANTIGEN (CEA) RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED FOR PATIENT 1 ON THE SAME INSTRUMENT, ALSO RESULTING LOWER. AFTER TROUBLESHOOTING, BOTH THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT, RESULTING HIGHER. IT IS UNKNOWN IF THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW PSA, CA 15-3 AND CEA RESULTS.

Additional Manufacturer Narrative

A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) SPECIALIST WAS DISPATCHED TO THE CUSTOMER SITE. THE CSE CHECKED THE WASH STATION AND CALIBRATED THE REAGENT PROBES. THE CSE ALSO CLEANED THE SAMPLE DILUTOR AND THE LUMINOMETER. THE CUSTOMER RAN THE PATIENT SAMPLES AFTER SYSTEM CHECK, WHICH RESULTED AS PER EXPECTATIONS. THE CUSTOMER DID NOT OBSERVE ANY FURTHER DISCORDANT RESULTS. THE CAUSE OF DISCORDANT, FALSELY LOW PSA, CA 15-3 AND CEA RESULTS ON PATIENT SAMPLES IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.