ATELLICA IM

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER REPORTED AN OBSERVATION OF AN 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. QUALITY CONTROL (QC) AND CALIBRATION SHOWED RECOVERIES WITHIN ACCEPTABLE RANGES, AND NO ANOMALIES WERE REPORTED IN THE OTHER PATIENT SAMPLES, INDICATING THAT THE ANALYZER AND REAGENT WERE PERFORMING AS EXPECTED. SIEMENS¿ REVIEW INDICATED A POTENTIAL ISSUE WITH SAMPLE INTEGRITY OR QUALITY AT THE CUSTOMER¿S SITE. THE PRESENCE OF CELLULAR DEBRIS, LIKELY DUE TO IMPROPER SPECIMEN HANDLING, IS A PLAUSIBLE FACTOR CONTRIBUTING TO THE PATIENT¿S INITIALLY ELEVATED VB12 RESULT, WHICH NORMALIZED UPON RETESTING WITH DILUTION AND/OR SERUM SETTLING AFTER AN EXTENDED TIME BETWEEN SAMPLE TESTS. 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 DUE TO A SAMPLE INTEGRITY OR QUALITY ISSUE. A PRODUCT PROBLEM HAS NOT BEEN IDENTIFIED. THE CUSTOMER IS OPERATIONAL.

Description of Event or Problem

THE CUSTOMER REPORTED AN OBSERVATION OF AN ELEVATED ATELLICA IM VITAMIN B12 (VB12, LOT# 302) PATIENT RESULT FOR A SAMPLE, WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. THE INITIAL DISCORDANT 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 MATCHED THE PATIENT¿S CLINICAL ASSESSMENT AND 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.