ADVIA CENTAUR XP

Description of Event or Problem

ONE NEGATIVE ADVIA CENTAUR EXP HCV PATIENT RESULT WAS OBTAINED. UPON REPEAT ON TWO OTHER SYSTEMS THE HCV RESULTS WERE CLEARLY POSITIVE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HCV RESULT.

Additional Manufacturer Narrative

A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT HCV WAS NOT A MALFUNCTION OF THE INSTRUMENT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.