ADVIA CENTAUR XP

Description of Event or Problem

A DISCORDANT, FALSE NEGATIVE HEPATITIS C VIRUS (HCV) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON AN ADVIA CENTAUR XP INSTRUMENT. THE SAMPLE RESULTED POSITIVE DURING AN INITIAL RUN. IT WAS THEN RERUN IN DUPLICATE, AND THE FIRST REPLICATE RESULTED POSITIVE BUT THE SECOND REPLICATE RESULTED NEGATIVE. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S), BUT THE NURSES WERE ALERTED THAT ONE OF THE RERUN RESULTS WAS NEGATIVE. AN ALTERNATE TUBE FROM THE SAME PATIENT WAS THEN TESTED THREE TIMES ON THE SAME INSTRUMENT AND RESULTED POSITIVE EACH TIME. THE POSITIVE RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSE NEGATIVE HCV 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 THE PINCH VALVE TUBING FOR ASPIRATE PROBES 1, 2, AND 3 WAS WORN. THE FSE REPLACED THE TUBING, CALIBRATED THE MOVEMENT OF THE SAMPLE PROBE TO THE CUVETTE BOTTOM, AND PROACTIVELY REPLACED THE SAMPLE SYRINGE. EIGHTEEN REPLICATES OF POSITIVE AND NEGATIVE QUALITY CONTROLS WERE THEN RUN, ALL OF WHICH WERE WITHIN RANGE. THE SAMPLE HAD BEEN RUN ON THE INSTRUMENT AND RESULTED AS EXPECTED PRIOR TO SERVICE. THE CAUSE OF THE DISCORDANT, FALSE NEGATIVE HCV RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.