ATELLICA IM

Additional Manufacturer Narrative

A OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) AND REPORTED OBSERVATION OF AN ELEVATED ATELLICA IM VITAMIN B12 (VB12) RESULT ON ONE PATIENT SAMPLE WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. SIEMENS REVIEWED PRIMARY AND ANCILLARY REAGENT USAGE ASSOCIATED WITH THE REPORTED DISCORDANT SAMPLE. QUALITY CONTROL (QC) PERFORMED ON THE ANCILLARY AND PRIMARY PACK ON THE DAY OF PATIENT TESTING WAS WITHIN ESTABLISH QC RANGES. SUBSEQUENT TESTING USING ALTERNATE PRIMARY AND ANCILLARY REAGENT PACKS PRODUCED ACCEPTABLE QC AND PATIENT RESULTS, AND NO ADDITIONAL VB12 ASSAY DISCREPANCIES WERE REPORTED. RETURN OF THE PATIENT SAMPLE FOR FURTHER INVESTIGATION WAS DEEMED UNNECESSARY, AS THE DISCORDANT RESULT COULD NOT BE REPRODUCED. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE FALSELY ELEVATED VB12 RESULT WAS UNABLE TO BE DETERMINED. A PRODUCT PROBLEM HAS NOT BEEN IDENTIFIED. THE CUSTOMER IS OPERATIONAL. NO FURTHER EVALUATION IS REQUIRED.K.

Description of Event or Problem

THE CUSTOMER REPORTED OBSERVATION OF AN ELEVATED ATELLICA IM VITAMIN B12 (VB12) RESULT ON ONE PATIENT SAMPLE WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING LOT# 304. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED ON AN ALTERNATE ATELLICA IM ANALYZER. THE REPEAT RESULT WAS CONSIDERED CORRECT. HOWEVER, A CORRECTED REPORT WAS NOT ISSUED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.