A SIEMENS'S CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE CSE PERFORMED A TOTAL SERVICE CALL. THE CSE FOUND THE WASH DISPLACEMENT DILUTER WAS LETTING AIR INTO THE LINE. THE CSE REPLACED AND PRIMED THE WASH DISPLACEMENT DILUTER. THE CUSTOMER PERFORMED QUALITY CONTROL (QC), RESULTING IN RANGE. A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST REVIEWED THE EVENT. HSC STATED THAT THE WASH DISPLACEMENT DISPENSE IS NOT USED FOR THE CARCINOEMBRYONIC ANTIGEN METHOD. THIS EVENT WAS THE ONLY INSTANCE OF A DISCORDANT RESULT AND WAS NOT REPRODUCED. THE CAUSE OF THE DISCORDANT, FALSELY DEPRESSED CARCINOEMBRYONIC ANTIGEN RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
D
Patient 1
A DISCORDANT, FALSELY DEPRESSED CARCINOEMBRYONIC ANTIGEN RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CENTAUR XP INSTRUMENT. THE INITIAL RESULT WAS REPORTED OUT TO THE PHYSICIAN(S), WHICH WAS QUESTIONED. THE CUSTOMER REPEATED THE SAME SAMPLE ON THE SAME ADVIA CENTAUR INSTRUMENT TWICE, RESULTING HIGHER. THE CUSTOMER FILED A CORRECTED REPORT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED CARCINOEMBRYONIC ANTIGEN RESULT.