BCS XP SYSTEM

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED SIEMENS CUSTOMER CARE CENTER TO REPORT DISCORDANT RESULTS THAT WERE OBTAINED ON FOUR DIFFERENT PATIENT SAMPLES ON THE BCS XP INSTRUMENT. BASED ON THE REVIEW OF INFORMATION PROVIDED, ISSUES WITH THE TUBING SYSTEM OF THE BCS XP WERE OBSERVED WHICH CAUSED DISCORDANT RESULTS OF THE TESTS INNOVANCE AT; LA1; PROC AC R.ACT; PROC AC R.NACL; INNOVANCE VWF AC. SIEMENS SERVICE REPLACED THE COMPLETE WET SYSTEM AND REAGENT PROBE AND VERIFIED THE SYSTEM ADJUSTMENTS. THE SYSTEM STATUS WAS CONFIRMED THROUGH VALIDATION PERFORMED WITH AN ANALYZER VALIDATION KIT. THE VALIDATION DEMONSTRATED EXCELLENT SYSTEM PERFORMANCE, AND THE SYSTEM IS OPERATIONAL. NOTE: BCS XP IS MARKETED IN THE UNITED STATES UNDER MATERIAL NUMBER 10459330. THE 510(K) NUMBERED DOCUMENTED IN SECTION G4 IS FOR THIS PRODUCT.

Description of Event or Problem

THE CUSTOMER REPORTED FALSE DEPRESSED RESULTS FOR THE TESTS, INNOVANCE ANTITHROMBIN; LA 1 SCREENING REAGENT; PROC AC R (RATIO); INNOVANCE VWF-AC. RESULTS WERE OBTAINED ON FOUR PATIENT SAMPLES ON A BCSXP INSTRUMENT. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT. THE REPEAT RESULTS WERE IN THE NORMAL RANGE. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE DEPRESSED RESULTS.