ADVIA CENTAUR CP

Additional Manufacturer Narrative

THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). THE CUSTOMER INFORMED THE CCC SPECIALIST THAT THE OPERATOR DID NOT DISCONNECT THE BLEACH AND RECONNECT THE WATER AND WASH 1 SOLUTION AFTER PERFORMING THE DAILY CLEANING PROCEDURE. THE OPERATOR REPEATED ALL THE SAMPLES WHICH WERE RUN DURING THE TIME THE BLEACH WAS CONNECTED TO THE SYSTEM. CCC INSTRUCTED THE CUSTOMER TO RECONNECT THE TUBING, PERFORM THE DAILY CLEANING PROCEDURES AND RUN QUALITY CONTROLS. THE CAUSE OF THE DISCORDANT, FALSELY LOW BNP RESULTS IS DUE TO A USER ERROR. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

Description of Event or Problem

DISCORDANT, FALSELY LOW BRAIN NATRIURETIC PEPTIDE (BNP) RESULTS WERE OBTAINED ON FOUR PATIENT SAMPLES ON AN ADVIA CENTAUR CP INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE OPERATOR DISCOVERED THE DISCORDANT RESULTS WHEN PERFORMING A LOOK BACK AFTER QUALITY CONTROLS WERE RUN AND RESULTED OUT OF RANGE FOR ALL ASSAYS. THE SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT, RESULTING HIGHER. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW BNP RESULTS.