ATELLICA CI CARCINOEMBRYONIC ANTIGEN (CEA)

Additional Manufacturer Narrative

SIEMENS FILED MDR 1219913-2025-00102 INITIAL REPORT ON 27-MAY-2025. SIEMENS COMPLETED INVESTIGATION OF AN OUTSIDE THE UNITED STATES (OUS) CUSTOMER REPORT OF AN ELEVATED ATELLICA CI CARCINOEMBRYONIC ANTIGEN (CEA) LOT: 222 PATIENT SAMPLE RESULT THAT WAS DISCORDANT RELATIVE TO A LOWER RETEST RESULT. THE CUSTOMER REPORTED IMPRECISION WITH THE CEA ASSAY LOT: 222 ON THE ATELLICA CI#: IRC006202322 OBSERVING VARIATION BETWEEN RUNS AT THE LOW END OF THE ASSAY ANALYTICAL MEASURING RANGE (AMR), WHICH LED TO THE DISCORDANCE. SIEMENS CONFIRMED THAT THE CUSTOMER IS PERFORMING THE REQUIRED SPECIAL REAGENT MIXING REQUIREMENT IN THE ASSAY'S INSTRUCTIONS FOR USE (IFU) AND INSPECTING ALL PACKS FOR CLUMPING AND PARTICLE SETTLING PRIOR TO LOADING ONTO THE ANALYZER. NO RELATED SHIPMENT/STORAGE/HANDLING CONDITIONS WERE REPORTED OR IDENTIFIED, BUT FAINT BANDS WERE OBSERVED ON THE ONBOARD REAGENT READYPACKS. THE CUSTOMER BEGAN USE OF REAGENT LOT: 222 ON 04-APR-2025. SIEMENS REVIEWED THE ATELLICA CI ANALYZER DATA SUMMARY EXTRACTION FILE FOR CEA ON ATELLICA CI#: IRC006202322 WITH DATE RANGE OF 01-APRIL-2025 TO 07-MAY-2025. SIEMENS' ANALYSIS CONFIRMED THERE WAS NO CALIBRATION RELATED PROBLEM. HOWEVER, IMPRECISION WAS NOTED ON FOUR DIFFERENT PATIENT SAMPLES TESTED BETWEEN 16-APR-2025 THROUGH 27-APR-2025, TESTED WITH DIFFERENT REAGENT READYPACKS OF LOT: 222. THERE HAS BEEN NO RECURRENCE OF IMPRECISION BESIDES THESE SAMPLES. THERE WAS NO HEMOLYSIS, ICTERUS, AND LIPEMIA (HIL) NOTED WITH THE SAMPLES. SIEMENS REVIEWED THE INDIVIDUAL TRACE FILES FOR THE FOUR SAMPLE REPLICATES, AND THEY DID NOT SHOW ANY SPECIFIC SIGNATURE THAT WOULD LEAD TO IMPRECISION OR OUTLIER IN THE DATA. HOWEVER, THERE WERE INDICATIONS OF ELECTRICAL INTERFERENCE RELATED TO A PARTICULAR ANALYZER PART. SIEMENS RECOMMENDED PART REPLACEMENT, BUT THE CUSTOMER STATED THAT THEY BEGAN USE OF A DIFFERENT REAGENT LOT, WILL BE MONITORING THE SYSTEM AND CONFIRMED NO FURTHER SUPPORT WAS REQUIRED AT THIS TIME. BASED ON THE INVESTIGATION, THE CAUSE OF THE DISCORDANT RESULT CANNOT BE CONFIRMED, BUT APPEARS TO BE RELATED TO ELECTRICAL INTERFERENCE DUE TO POTENTIAL PART MALFUNCTION. A PRODUCT ISSUE WAS NOT IDENTIFIED. THE CUSTOMER IS OPERATIONAL, AND THE REPORTED ISSUE WAS RESOLVED BY ROUTINE TROUBLESHOOTING. IN SECTION H6 OF THIS REPORT, THE INVESTIGATION FINDING AND CONCLUSION CODES WERE UPDATED BASED ON THE INVESTIGATION RESULTS.

Additional Manufacturer Narrative

THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES (OUS). THE OUS CUSTOMER REPORTED AN OBSERVATION OF AN ELEVATED ATELLICA CI CARCINOEMBRYONIC ANTIGEN (CEA) LOT 222 PATIENT SAMPLE RESULT WITH THAT WAS DISCORDANT RELATIVE TO A LOWER RETEST RESULT. THE CUSTOMER IS AWARE OF THE SPECIAL REAGENT MIXING REQUIREMENT IN THE ASSAY'S INSTRUCTIONS FOR USE (IFU) BUT HAS OBSERVED REAGENT CLUMPING AND HIGH CV ON THE CALIBRATORS. THE ASSAY'S INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING, UNDER INTERPRETATION OF RESULTS: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS." SIEMENS IS INVESTIGATING.

Description of Event or Problem

THE CUSTOMER OBTAINED AN ELEVATED PATIENT SAMPLE RESULT WITH ATELLICA CI CARCINOEMBRYONIC ANTIGEN (CEA) LOT 222 THAT WAS DISCORDANT RELATIVE TO A LOWER RETEST RESULT. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.