ATELLICA IM VITAMIN B12 (VB12)

Description of Event or Problem

THE CUSTOMER OBTAINED A DISCORDANT ELEVATED ATELLICA IM 1600 VITAMIN B12 (VB12) RESULT ON A PATIENT SAMPLE USING LOT 285. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THE SAMPLE WAS REPEATED ON THE SAME ATELLICA IM ANALYZER, AND THE RESULT WAS LOWER. THE LOWER RESULT WAS CONSIDERED AS CORRECT BY THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED VB12 PATIENT RESULT.

Additional Manufacturer Narrative

AN OUTSIDE THE UNITED STATES CUSTOMER OBTAINED A DISCORDANT ELEVATED ATELLICA IM 1600 VITAMIN B12 (VB12) RESULT ON A PATIENT SAMPLE USING LOT 285. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THE SAMPLE WAS REPEATED ON THE SAME ATELLICA IM ANALYZER, AND THE RESULT WAS LOWER. THE LOWER RESULT WAS CONSIDERED AS CORRECT BY THE PHYSICIAN(S). SIEMENS INVESTIGATION INCLUDED AN ASSESSMENT OF REAGENT, INSTRUMENT, AND SAMPLE DATA. THE CUSTOMER INFORMED THE LOCAL TEAM THAT AN OPERATIONAL FAILURE OCCURRED WHEN PREPARING THE ANCILLARY DTT FOR VB12. THE CUSTOMER POTENTIALLY MAY HAVE INSUFFICIENTLY MIXED THE DTT REAGENT DURING PREPARATION, ALLOWED REAGENT TO SIT BEFORE PLACING IN REAGENT COMPARTMENT OR DIVERGED FROM APPROPRIATE VOLUMES DURING MANUAL REAGENT PREPARATION RESULTING IN DISCORDANT RESULTS AS THE REAGENT VOLUME DEPLETES. THE CUSTOMER SHOULD REVIEW PROPER PREPARATION AND HANDLING OF THE DTT/RELEASING AGENT AS DIRECTED IN THE PREPARING THE REAGENTS SECTON OF THE ATELLICA IM VITAMIN B12 (VB12) INSTRUCTIONS FOR USE (IFU), 10995437_EN REV. 02, 2019-08. THE INTERPRETATION OF RESULTS SECTION OF THE ATELLICA IM VITAMIN B12 (VB12) INSTRUCTIONS FOR USE (IFU) STATES: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS." BASED ON THE INFORMATION PRESENTED, SIEMENS CANNOT RULE OUT ISSUES WITH THE ANCILLARY REAGENT BEING COMPROMISED FOR THE CAUSE DISCORDANT PATIENT RESULT. THE CUSTOMER IS CURRENTLY OPERATIONAL.