ADVIA CENTAUR CP

Description of Event or Problem

DISCORDANT B-TYPE NATRIURETIC PEPTIDE (BNP) RESULTS WERE OBTAINED ON FIVE PATIENT SAMPLES AND A DISCORDANT, FALSELY LOW INTACT PARATHYROID HORMONE (IPTH) RESULT WAS OBTAINED ON ONE INTRA-OPERATIVE PATIENT SAMPLE ON AN ADVIA CENTAUR CP INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THEM. THE CUSTOMER RAN QUALITY CONTROLS, WHICH RESULTED OUT OF RANGE. THE CUSTOMER REPEATED THE PATIENT SAMPLES ON AN ADVIA CENTAUR XP INSTRUMENT, RESULTING AS EXPECTED. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT BNP AND IPTH RESULTS.

Additional Manufacturer Narrative

A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE DISCOVERED THAT THE CLEANING SOLUTION WAS STILL CONNECTED TO THE INSTRUMENT AFTER THE DAILY CLEANING PROCEDURE. THE CSE RECONNECTED THE WATER AND PRIMED THE SYSTEM TWICE TO RINSE THE CLEANING SOLUTION OUT. THE CUSTOMER THEN RAN QUALITY CONTROLS, WHICH RESULTED WITHIN RANGE. THE CAUSE OF THE DISCORDANT BNP AND IPTH RESULTS IS A USER ERROR. THIS EVENT ALSO IDENTIFIES AN OFF-LABEL USE AS THE ADVIA CENTAUR XP IPTH ASSAY IS NOT CLEARED FOR INTRA-OPERATIVE USE. THE INSTRUCTION FOR USE (IFU) STATES IN THE INTENDED USE SECTION THE FOLLOWING: "FOR IN VITRO DIAGNOSTIC USE IN THE QUANTITATIVE DETERMINATION OF INTACT PARATHYROID HORMONE (IPTH) IN EDTA PLASMA OR SERUM USING THE ADVIA CENTAUR CP SYSTEM. THIS ASSAY IS INTENDED TO BE USED TO AID IN THE DIFFERENTIAL DIAGNOSIS OF HYPERPARATHYROIDISM, HYPOPARATHYROIDISM, OR HYPERCALCEMIA OF MALIGNANCY." THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.