ADVIA CENTAUR

Description of Event or Problem

A DISCORDANT, (B)(6) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON AN ADVIA CENTAUR INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RERUN AND RESULTED (B)(6). IT IS UNKNOWN WHAT INSTRUMENT THE SAMPLE WAS REPEATED ON. THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, (B)(6) RESULT.

Additional Manufacturer Narrative

A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS INFORMED THAT THE OPERATOR OF AN ADVIA CENTAUR INSTRUMENT OBSERVED LOW QUALITY CONTROL RESULTS. IT WAS THEN DISCOVERED THAT A BOTTLE OF ACID REAGENT HAD BEEN INSTALLED IN THE WASH 1 REAGENT BOTTLE POSITION. THE OPERATOR RERAN PATIENT SAMPLES THAT HAD RUN AFTER THE ACID REAGENT BOTTLE WAS INCORRECTLY PLACED ON THE INSTRUMENT AND DETERMINED THAT ONE DISCORDANT, (B)(6) RESULT HAD BEEN OBTAINED. A SIEMENS GLOBAL PRODUCT SUPPORT SPECIALIST CONFIRMED WITH THE CUSTOMER THAT THE INSTRUMENT HAD COLOR-CODED LABELS AND THAT THE OPERATOR HAD BEEN TRAINED IN PROPER PLACEMENT OF REAGENT BOTTLES. THE CAUSE OF THE DISCORDANT, (B)(6) RESULT ON ONE PATIENT SAMPLE IS USER ERROR. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.