ADVIA CENTAUR

Additional Manufacturer Narrative

THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). DURING TROUBLESHOOTING, THE CUSTOMER INFORMED THE TSC SPECIALIST THAT THE SAMPLE HAD BEEN RUN WITHOUT A BARCODE WHEN IT RESULTED NON-REACTIVE. THERE IS NO TRACEABILITY TO THE SAMPLE BECAUSE IT WAS RUN WITHOUT A BARCODE, AND THEREFORE IT IS UNKNOWN IF THE CORRECT SAMPLE WAS TESTED DURING THE INITIAL RUN. THE PATIENT SAMPLE RESULTED AS EXPECTED WHEN TESTED ON THE SAME INSTRUMENT. THERE WERE NO KNOWN ISSUES WITH ANY OTHER AHCV RESULTS OR ANY OTHER ASSAY RESULTS. THE CAUSE OF THE DISCORDANT, FALSE NON-REACTIVE AHCV RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

Description of Event or Problem

A DISCORDANT, FALSE NON-REACTIVE (B)(6) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON AN ADVIA CENTAUR INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RERUN ON THE SAME INSTRUMENT AND RESULTED AS REACTIVE. THE RERUN 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.