ATELLICA IM BR 27.29 (BR)

Additional Manufacturer Narrative

THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ATELLICA IM BR 27.29 (BR) RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING. SIEMENS IS INVESTIGATING. NOTE: SIMILAR EVENTS ASSOCIATED WITH OTHER OBSERVATION DATES ARE REPORTED SEPARATELY.

Description of Event or Problem

THE CUSTOMER REPORTS OBSERVATION OF ELEVATED QUALITY CONTROL (QC) AND DISCORDANT PATIENT RESULTS WHEN RUNNING ATELLICA IM BR 27.29 (BR) LOT: 275 WHEN REMAINING REAGENT VOLUME IS LOW. THE CUSTOMER COMPLAINED OF ELEVATED QC RESULTS PRODUCED WHEN FEWER TESTS (<30) ARE REMAINING IN THE BR 27.29 REAGENT PACK. THIS ISSUE WAS SEEN ACROSS ALL THREE ATELLICA IM ANALYZERS IN THIS LAB. ADDITIONAL TESTING USING DILUTED CONTROL MATERIAL DEMONSTRATED A SIMILAR EFFECT. ON (B)(6) 2026, THE CUSTOMER PROVIDED DATA INDICATING THAT DISCORDANT PATIENT RESULTS HAD BEEN OBSERVED IN ASSAY RUNS WHERE QC HAD FAILED. DATA WERE PROVIDED FOR SEVERAL MONTHS OF OBSERVATIONS, WHERE QC RESULTS WERE OUTSIDE EXPECTED RANGES, AND PATIENT SAMPLES WHICH HAD BEEN TESTED SINCE THE LAST PASSING QC WERE RE-TESTED. RESULTS FOR PATIENT SAMPLES WHICH HAD BEEN SUBJECTED TO REPEAT TESTING WERE PROVIDED. FOR TWO OF THE SAMPLES, THE OBSERVED DIFFERENCE BETWEEN INITIAL AND REPEAT TESTS WAS GREATER THAN 30%, AND INITIAL RESULTS WERE ABOVE THE ASSAY'S REFERENCE THRESHOLD OF 38.6 U/ML, WHILE REPEAT RESULTS WERE BELOW. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.