ATELLICA IM

Additional Manufacturer Narrative

AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING THE ERRONEOUSLY ELEVATED VITAMIN B12 (VB12) RESULTS OBTAINED ON MULTIPLE PATIENT SAMPLES ON THE ATELLICA IM 1600 ANALYZER. SIEMENS REVIEWED THE INSTRUMENT DATA, INFORMATION PROVIDED BY THE CUSTOMER. BASED ON THE REVIEW, REAGENT AND INSTRUMENT ISSUES WERE RULED OUT BASED ON QUALITY CONTROL (QC) AND CALIBRATION RECOVERY WITHIN ACCEPTABLE RANGES AND NO ISSUES WERE REPORTED WITH OTHER PATIENT SAMPLES. RETURN OF THE PATIENT SAMPLE FOR FURTHER INVESTIGATION IS NOT WARRANTED BECAUSE DISCORDANT RESULT WAS NOT REPRODUCIBLE. BASED ON THE AVAILABLE INFORMATION, SIEMENS DETERMINED THAT THE POTENTIAL CAUSE OF THE DISCORDANT RESULT WAS ATTRIBUTABLE TO AN ISSUE WITH THE ANCILLARY DTT REAGENT. CUSTOMER IS OPERATIONAL AND NO FURTHER ACTIONS ARE REQUIRED.

Description of Event or Problem

THE CUSTOMER REPORTED OBSERVATION OF ERRONEOUSLY ELEVATED VITAMIN B12 (VB12) RESULTS OBTAINED ON MULTIPLE PATIENT SAMPLES ON THE ATELLICA IM 1600 ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPEATED ON AN ALTERNATE ANALYZER. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.