ADVIA CENTAUR XP

Additional Manufacturer Narrative

A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE TO EVALUATE THE INSTRUMENT AND INSTRUMENT DATA. THE CSE DISCOVERED REAGENT PROBE 1 DISPLAYED SYSTEM ERRORS WHEN COMMENCING FAULT FINDING FOR THE CHIV ASSAY PROBLEM. THE CSE REMOVED THE REAGENT PROBE 1 ASSEMBLY AND CLEANED THE IN-OUT OPTICAL SENSOR ARRAY. THE CSE ALSO REPLACED A FAULTY SEPARATION MANIFOLD AND PERFORMED A TOTAL SERVICE CALL ON THE INSTRUMENT. THE CSE WAS INVOLVED WITH EXTENSIVE TROUBLESHOOTING, WHICH REQUIRED MULTIPLE CUSTOMER SITE VISITS. THE CAUSE OF THE DISCORDANT CHIV RESULT IS UNKNOWN. THE CSE SUCCESSFULLY RAN CALIBRATIONS AND QC. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

Description of Event or Problem

A DISCORDANT, FALSE NEGATIVE C HUMAN IMMUNOVIRUS (CHIV) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON AN ADVIA CENTAUR XP INSTRUMENT. THE DISCORDANT CHIV RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED FOUR TIMES ON AN ALTERNATE INSTRUMENT. IT IS UNKNOWN WHAT REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PATIENT INTERVENTION DUE TO THE DISCORDANT CHIV RESULTS.