ATELLICA IM

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER REPORTED AN OBSERVATION OF ELEVATED ATELLICA IM VITAMIN B12 (VB12) PATIENT RESULT FOR A SAMPLE, WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. SIEMENS EVALUATED THE INSTRUMENT DATA, AND THE INFORMATION PROVIDED BY THE CUSTOMER. SIEMENS REVIEWED REAGENT AND ANCILLARY REAGENT USAGE RELATED TO THE AFFECTED SAMPLE. QUALITY CONTROL (QC) RESULTS FOR THE ANCILLARY DILUTION TRAY TURNTABLE (DTT) PACKS AND PRIMARY PACK REAGENTS WERE OUTSIDE THE CUSTOMER-DEFINED RANGE ON THE DAY OF THE EVENT. SUBSEQUENT TESTING USING ALTERNATE PRIMARY AND ANCILLARY PACKS PRODUCED ACCEPTABLE RESULTS, AND NO FURTHER VB12 ASSAY ISSUES WERE OBSERVED. SIEMENS FURTHER EVALUATED THE EVENT AND DETERMINED THAT THE CALIBRATION IN USE ON THE DAY OF THE EVENT MIGHT HAVE AFFECTED THE VB12 RESULT BY CREATING A SLIGHT POSITIVE BIAS. AFTER PERFORMING THE NEW CALIBRATION, THE VB12 RESULT RETURNED TO THE EXPECTED VALUE. RETURN OF THE PATIENT SAMPLE FOR ADDITIONAL INVESTIGATION WAS NOT REQUIRED BECAUSE THE DISCORDANT RESULT WAS NOT REPRODUCIBLE. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE DISCORDANT VB12 RESULT WAS UNABLE TO BE DETERMINED. A PRODUCT PROBLEM HAS NOT BEEN IDENTIFIED. THE CUSTOMER IS OPERATIONAL.

Description of Event or Problem

THE CUSTOMER REPORTED AN OBSERVATION OF ELEVATED ATELLICA IM VITAMIN B12 (VB12, LOT# 302) PATIENT RESULT FOR A SAMPLE, WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RETESTED ON AN ALTERNATE ATELLICA IM 1600 ANALYZER, WHICH YIELDED A LOWER RESULT. THE LOWER RETESTED RESULT WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.