ADVIA CENTAUR XP B-TYPE NATRIURETIC PEPTIDE (BNP)

Additional Manufacturer Narrative

THE CAUSE FOR THE ELEVATED QC AND PATIENT RESULTS WITH ADVIA CENTAUR XP BNP REAGENT LOT 188 AND CALIBRATOR 38 LOT 61 IS UNKNOWN. 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 OBSERVED A HIGH BIAS FOR A PATIENT SAMPLE WHEN USING ADVIA CENTAUR XP BNP REAGENT LOT ENDING IN 188 WHEN COMPARED TO THE RESULT USING ADVIA CENTAUR BNP REAGENT LOT ENDING IN 186. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR XP BNP RESULT.

Additional Manufacturer Narrative

MDR 1219913-2017-00042 WAS FILED ON FEBRUARY 27, 2017 REGARDING A HIGH BIAS FOR A PATIENT SAMPLE WHEN USING ADVIA CENTAUR XP BNP REAGENT LOT ENDING IN 188 WHEN COMPARED TO THE RESULT USING ADVIA CENTAUR BNP REAGENT LOT ENDING IN 186. 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. THE CUSTOMER IS RUNNING A NEW LOT NUMBER OF REAGENT AND PRODUCED QC WITHIN RANGE.