ADVIA CENTAUR XP B-TYPE NATRIURETIC PEPTIDE (BNP)

Additional Manufacturer Narrative

MDR 1219913-2016-00268 WAS FILED ON JANUARY 9, 2017 REPORTING THAT THE CUSTOMER WAS PERFORMING A STUDY WHEN MOVING TO A NEW REAGENT LOT OF ADVIA CENTAUR XP BNP AND OBSERVED HIGH, OUT OF RANGE QC, MASTER CURVE MATERIAL AND PATIENT SAMPLE RESULTS COMPARED TO THE PREVIOUS LOT. THE MDR ALSO NOTED THAT CALIBRATION OF ADVIA CENTAUR XP BNP REAGENT LOT 188 WITH CALIBRATOR LOT 38 LOT 62 SHOWED ACCEPTABLE QC AND MCM RESULTS AND PATIENT RESULTS THAT ARE CLOSER TO THOSE OBTAINED WITH ADVIA CENTAUR XP BNP REAGENT LOT 185 AND CALIBRATOR 38 LOT 61. THE CUSTOMER TRIED TO RE-CALIBRATE AGAIN WITH ADVIA CENTAUR XP BNP REAGENT LOT 188 AND FAILED CALIBRATION DUE TO LOW CAL DEVIATION FAILURES. FEBRUARY 9, 2017 - ADDITIONAL INFORMATION SIEMENS DISTRIBUTED CUSTOMER NOTIFICATION CC 17-08.A.US AND CC 17-08.A.OUS ADVIA CENTAUR SYSTEMS B-TYPE NATRIURETIC PEPTIDE (BNP) CALIBRATION FAILURES TO CUSTOMERS IN THE US AND OUS RESPECTIVELY ON JANUARY 14, 2017. THESE COMMUNICATIONS ADVISED THAT SIEMENS' INVESTIGATION HAS CONFIRMED THAT THE 'LOW CALIBRATOR DEVIATION' CALIBRATION PARAMETER MAY FALL BELOW THE ACCEPTABLE RANGE FOR THESE LOTS, CAUSING AN INVALID CALIBRATION STATUS WHICH PREVENTS CUSTOMERS FROM GENERATING RESULTS FOR THE BNP ASSAY. WHEN VALID CALIBRATION AND QUALITY CONTROL (QC) ARE OBTAINED, PATIENT RESULTS ARE VALID AND ACCEPTABLE FOR REPORTING. WHEN VALID CALIBRATION IS NOT ACHIEVED, QC AND PATIENT TESTING CANNOT BE PERFORMED. AT THIS TIME, SIEMENS CONSIDERS ALL ADVIA CENTAUR SYSTEMS BNP REAGENT LOTS AS POTENTIALLY IMPACTED. SIEMENS CONTINUES TO INVESTIGATE THE HIGH BIAS THAT THE CUSTOMER INITIALLY OBSERVED WITH ADVIA CENTAUR XP BNP REAGENT LOT 185 AND CALIBRATOR 38 LOT 61.

Additional Manufacturer Narrative

THE CAUSE FOR THE ELEVATED QC, MCM AND PATIENT RESULTS WITH ADVIA CENTAUR XP BNP REAGENT LOT 188 AND CALIBRATOR 38 LOT 61 IS UNKNOWN. QC WAS OUT OF RANGE HIGH WHEN THE CUSTOMER PROCEEDED TO TEST THE PATIENT SAMPLE IN THE STUDY. SIEMENS SERVICE WENT ON SITE AND FOUND THE SYSTEM TO BE PERFORMING PROPERLY. CALIBRATION OF ADVIA CENTAUR XP BNP REAGENT LOT 188 WITH CALIBRATOR LOT 38 LOT 62 SHOWED ACCEPTABLE QC AND MCM RESULTS AND PATIENT RESULTS THAT ARE CLOSER TO THOSE OBTAINED WITH ADVIA CENTAUR XP BNP REAGENT LOT 185 AND CALIBRATOR 38 LOT 61. THE CUSTOMER TRIED TO RE-CALIBRATE AGAIN WITH ADVIA CENTAUR XP BNP REAGENT LOT 188 AND IS NOW FAILING CALIBRATION DUE TO LOW CAL DEVIATION FAILURES. SIEMENS CONTINUES TO INVESTIGATE. THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE STATES: "THE RESULTS OF THE ADVIA CENTAUR BNP ASSAY SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL EVALUATION AND OTHER DIAGNOSTIC PROCEDURES."

Description of Event or Problem

CUSTOMER WAS PERFORMING A STUDY WHEN MOVING TO A NEW REAGENT LOT OF ADVIA CENTAUR XP BNP AND OBSERVED HIGH, OUT OF RANGE QC, MASTER CURVE MATERIAL AND PATIENT SAMPLE RESULTS COMPARED TO THE PREVIOUS LOT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR XP BNP RESULTS.

Additional Manufacturer Narrative

MDR 1219913-2016-00268 WAS FILED ON JANUARY 9, 2017 REPORTING THAT THE CUSTOMER WAS PERFORMING A STUDY WHEN MOVING TO A NEW REAGENT LOT OF ADVIA CENTAUR XP BNP AND OBSERVED HIGH, OUT OF RANGE QC, MASTER CURVE MATERIAL AND PATIENT SAMPLE RESULTS COMPARED TO THE PREVIOUS LOT. THE MDR ALSO NOTED THAT CALIBRATION OF ADVIA CENTAUR XP BNP REAGENT LOT 188 WITH CALIBRATOR LOT 38 LOT 62 SHOWED ACCEPTABLE QC AND MCM RESULTS AND PATIENT RESULTS THAT ARE CLOSER TO THOSE OBTAINED WITH ADVIA CENTAUR XP BNP REAGENT LOT 185 AND CALIBRATOR 38 LOT 61. THE CUSTOMER TRIED TO RE-CALIBRATE AGAIN WITH ADVIA CENTAUR XP BNP REAGENT LOT 188 AND FAILED CALIBRATION DUE TO LOW CAL DEVIATION FAILURES. MDR 1219913-2016-00268 SUPPLEMENTAL 1 WAS FILED FEBRUARY 9, 2017 WITH INFORMATION REGARDING SIEMENS INVESTIGATION INTO CALIBRATION FAILURES WITH ADVIA CENTAUR BNP. MARCH 3, 2017 - ADDITIONAL INFORMATION SIEMENS PERFORMED A STUDY USING 3 LOTS OF QC AND 1 LOT OF MEDICAL DECISION POOL (MDP) RUN IN TRIPLICATE AND 20 PATIENT SAMPLES IN SINGLICATE (DOSE 10-360 PG/ML) WITH ADVIA CENTAUR BNP LOTS 185-191 WITH CAL 61 AND CAL 62. PATIENT SAMPLES ACCEPTABLE. INTERNAL QC AND MDPS WERE IN RANGE ON BOTH LOTS. ASSAY WORKS AS SPECIFIED.