ATELLICA IM VB12

Description of Event or Problem

THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM VITAMIN B12 (VB12) RESULT WITH LOT # 302, WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING ON THE ALTERNATE ANALYZER. THE CUSTOMER USES TWO PARAMETERS SUCH AS MOVING AVERAGE CONCEPT AND QUALITY CONTROL (QC) FOR ASSAY PERFORMANCE. ON THE DAY OF THE RESET, TWO MOVING AVERAGE FAILURES WITH NEGATIVE BIAS WERE OBSERVED. ALSO OBSERVED FAILED QC RESULTS ON ANCILLARY PACK OF 5446 AND 5562. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE ATELLICA IM ANALYZER. THE REPEAT RESULT RECOVERED LOWER THAN THE INITIAL RESULT AND MATCHED THE CLINICAL ASSESSMENT. THE REPEAT RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS OR TREATMENT RESULTING FROM THE OBSERVED RESULT DISCORDANCE.

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS REMOTE SERVICES CENTER (RSC) AND REPORTED OBSERVATION OF AN ELEVATED ATELLICA IM VITAMIN B12 (VB12) RESULT, WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING ON AN ALTERNATE ANALYZER. SIEMENS REVIEWED THE REAGENT AND ANCILLARY REAGENT USAGE RELATED TO THE REPORTED DISCORDANT SAMPLES. BIO-RAD QUALITY CONTROL (QC) PERFORMED ON THE ANCILLARY DILUTION TRAY TURNTABLE (DTT) PACKS USED FOR PATIENT TESTING WAS OUTSIDE OF CUSTOMER-DEFINED RANGE ON THE DAY OF PATIENT TESTING. IT WAS ALSO OBSERVED THAT MULTIPLE PACKS OF BOTH PRIMARY AND ANCILLARY REAGENTS WERE CONCURRENTLY IN USE ON THE ATELLICA IM ANALYZER DURING THE TIME OF PATIENT AND QC TESTING MAKING IT DIFFICULT TO EVALUATE QC PERFORMANCE FOR THE NUMEROUS COMBINATIONS OF PRIMARY AND ANCILLARY PACK REAGENTS. SUBSEQUENT TESTING USING ALTERNATE PRIMARY AND ANCILLARY PACKS PRODUCED ACCEPTABLE QC AND PATIENT RESULTS, AND NO FURTHER VB12 ASSAY ISSUES WERE REPORTED. SIEMENS FURTHER EVALUATED THE EVENT AND CONCLUDED THAT THE ANCILLARY DTT REAGENT THAT FAILED QC ON THE DAY OF PATIENT TESTING CONTRIBUTED TO THE ELEVATED VB12 RESULT. NO SYSTEMIC REAGENT OR INSTRUMENT PROBLEMS WERE IDENTIFIED. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.