ADVIA CENTAUR XP

Description of Event or Problem

A DISCORDANT, FALSELY LOW PROSTATE SPECIFIC ANTIGEN (PSA) RESULT WAS OBTAINED ON AN ADVIA CENTAUR XP INSTRUMENT ON ONE PATIENT SAMPLE. THE DISCORDANT RESULT WAS NOT RELEASED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON ANOTHER ADVIA CENTAUR XP INSTRUMENT AND RESULTED HIGHER. THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW PSA RESULT.

Additional Manufacturer Narrative

A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE FSE DISCOVERED THAT TUBING FOR THE RE-SUSPENSE TUBES HAD BEEN SWITCHED ON THE SYSTEM, CAUSING PATIENT SAMPLES TO BE DISPENSED INTO CUVETTES CONTAINING OTHER FLUIDS WHICH DILUTED THE SAMPLES. IT IS UNKNOWN IF THE FSE OR OPERATOR HAD INCORRECTLY PLACED THE TUBING ON THE SYSTEM. THE FSE FIXED THE TUBING, AND THE INSTRUMENT IS OPERATIONAL. THE CAUSE OF THE DISCORDANT, FALSELY LOW PSA RESULT IS A RE-SUSPENSE TUBING SWITCH UP. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.