ATELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA)

Description of Event or Problem

THE CUSTOMER REPORTS ELEVATED QUALITY CONTROL (QC) AND PATIENT RESULTS WHEN USING CARCINOEMBRYONIC ANTIGEN (CEA) LOT 224 (REAGENT PACK # (B)(6) ON ATELLICA IM ANALYZER# (B)(6). MULTIPLE PATIENT SAMPLES WERE TESTED WITH THE PACK IN QUESTION AND RESULTS WERE ELEVATED COMPARED TO RETEST RESULTS OBTAINED WHEN TESTING THE SAME SAMPLES WITH A DIFFERENT REAGENT PACK OF THE SAME LOT ON THE SAME ANALYZER. THE INITIAL RESULTS WERE REPORTED AND QUESTIONED BY PHYSICIANS. THERE ARE NO REPORTS OF ALTERED TREATMENT OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

Additional Manufacturer Narrative

THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES (OUS). THE OUS CUSTOMER REPORTS ELEVATED QUALITY CONTROL (QC) AND PATIENT RESULTS WHEN USING CARCINOEMBRYONIC ANTIGEN (CEA) LOT 224 (REAGENT PACK # (B)(6) ON ATELLICA IM ANALYZER# (B)(6). MULTIPLE PATIENT SAMPLES WERE TESTED WITH THE PACK IN QUESTION AND RESULTS WERE ELEVATED COMPARED TO RETEST RESULTS OBTAINED WHEN TESTING THE SAME SAMPLES WITH A DIFFERENT REAGENT PACK OF THE SAME LOT ON THE SAME ANALYZER. THE INITIAL RESULTS WERE REPORTED AND QUESTIONED BY PHYSICIANS. THERE ARE NO REPORTS OF ALTERED TREATMENT OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT. INITIAL REVIEW OF INFORMATION INDICATES THAT THERE WERE 6 REAGENT PACKS OF LOT 224 USED ON THIS ANALYZER WHERE 5 OF THE 6 PACKS RESULTED IN CONSISTENT, ACCEPTABLE (QUALITY CONTROL) QC RESULTS. ONLY PACK # (B)(6) PRODUCED ELEVATED RESULTS SUCH THAT APPROXIMATELY 300,000 RLUS (RELATIVE LIGHT UNITS) WERE ADDED TO EACH QC SAMPLE TESTED. THIS SUGGESTS A POTENTIAL REAGENT PACK CONTAMINATION. SIEMENS IS INVESTIGATING.

Additional Manufacturer Narrative

SIEMENS COMPLETED THE INVESTIGATION FOR AN OUTSIDE OF THE US CUSTOMER COMPLAINT OF FALSELY ELEVATED ATELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA) LOT 224 PATIENT RESULTS. THE CUSTOMER OBSERVED ELEVATED QUALITY CONTROL (QC) AND PATIENTS TESTED ON ONE REAGENT PACK OF CEA LOT 224 ON THE ATELLICA IM 1600 ANALYZER ON (B)(6) 2025. RESULTS WERE LOWER WHEN RETESTED WITH A DIFFERENT REAGENT PACK OF THE SAME LOT ON THE SAME ANALYZER. SIEMENS REVIEWED THE DEC RECORDS FROM ANALYZER # (B)(6) FOR 6 READY PACKS OF LOT 224 TESTED ON SEPTEMBER 3, 2025. 5 OF THE 6 READY PACKS PROVIDED CONSISTENT, ACCEPTABLE QC RESULTS. THERE WAS A CONSISTENT ~300,000 RLUS ADDED TO EVERY QC SAMPLE TESTED WITH REAGENT PACK # (B)(4) RELATIVE TO THE OTHER 5 REAGENT PACKS. BASED ON THIS INFORMATION THERE IS STRONG EVIDENCE OF LITE REAGENT CONTAMINATION INTO THE SOLID PHASE WELL OF THE REAGENT PACK FOR THIS SPECIFIC PACK. SIEMENS REVIEWED FIELD DATA FROM MORE THAN (B)(4) PACKS FROM ATELLICA IM CEA LOT 224 AND DID NOT IDENTIFY ANY PACKS THAT PERFORMED SIMILAR TO # (B)(4). SIEMENS REVIEWED ROUTINE INTERNAL REAGENT RELEASE DATE, SPECIFICALLY LOT UNIFORMITY TESTING, OF SAMPLES THE ~(B)(4) READY PACKS FILLED AND FOUND CONSISTENT NON-ELEVATED RLUS THROUGHOUT THE BATCH. REAGENT PACK # (B)(4) WAS A PACK FILLED NEARLY IN THE MIDDLE OF THE FILLING BATCH OF THE (B)(4) PACKS. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF EVENT CANNOT BE CONFIRMED, BUT APPEARS TO BE CONTAMINATION OF THE SOLID PHASE WELL OF REAGENT PACK # (B)(4) WITH LITE REAGENT WHICH CAN CAUSE HIGH RLUS AND DOSE, AS IT INTRODUCES EXCESS AE-LABELED ANTIBODY INTO THE REACTION, LEADING TO INCREASED LIGHT EMISSION AND POTENTIALLY FALSELY ELEVATED RESULTS. THERE IS NO EVIDENCE OF A SYSTEMIC REAGENT OR INSTRUMENT ISSUE AS OTHER REAGENT PACKS WERE NOT AFFECTED, AND NO ISSUES WERE REPORTED WITH OTHER PATIENT SAMPLE RESULTS. THE CUSTOMER IS OPERATIONAL USING OTHER REAGENT LOT 224 PACKS. SIEMENS FILED INITIAL MDR 1219913-2025-00174 ON 26-SEP-2025. IN SECTION H6 OF THIS REPORT, THE INVESTIGATION FINDING AND CONCLUSION CODES WERE UPDATED BASED ON THE INVESTIGATION RESULTS.