IMMULITE 2000 CEA

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR ON JUNE 14, 2023. AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER TO REPORT A FALSELY ELEVATED CEA RESULT, THAT WAS OBTAINED ON A SAMPLE FROM ONE PATIENT ON AN IMMULITE 2000 XPI INSTRUMENT. AND CONSIDERED DISCORDANT WITH THE LOWER REPEAT RESULT. JUNE 14, 2023, ADDITIONAL INFORMATION: BASED ON THE AVAILABLE INFORMATION, THE NONREPEATABLE ELEVATED IMMULITE 2000 XPI CEA RESULTS APPEAR TO BE, DUE TO SAMPLE INTEGRITY ISSUES. PREVIOUS INVESTIGATIONS OF THIS ISSUE AT THE CUSTOMER SITE RULED OUT SAMPLE CARRYOVER AS A CAUSE. AND THERE WERE NO ISSUES FOUND WITH THE CUSTOMER'S ANALYZER. SIEMEN¿S INTERNAL DATA DOES NOT DUPLICATE THE NONREPEATABLE ELEVATED IMMULITE 2000 XPI CEA RESULTS ISSUE SEEN BY THE CUSTOMER. THE MAIN DATABASE FILE FROM THE IMMULITE 2000 XPI S/N#: (B)(6) WILL BE PROVIDED TO SIEMENS FOR REVIEW TO DETERMINE, THE RATE OF NONREPEATABLE ELEVATED IMMULITE 2000 XPI CEA RESULTS. SIEMENS CONTINUES TO INVESTIGATE.

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 2432235-2023-00158 ON JUNE 14, 2023. SIEMENS FILED THE MDR 2432235-2023-00158 SUPPLEMENTAL REPORT 1 ON JULY 07, 2023. AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER TO REPORT A FALSELY ELEVATED CEA RESULT THAT WAS OBTAINED ON A SAMPLE FROM ONE PATIENT ON AN IMMULITE 2000 XPI INSTRUMENT AND CONSIDERED DISCORDANT WITH THE LOWER REPEAT RESULT. NOVEMBER 13, 2023 ADDITIONAL INFORMATION: THE CUSTOMER CHANGED THE VERSACELL® SET UP TO ALWAYS TEST SAMPLES ON THE IMMULITE 2000 FIRST TO SEE IF THE FLYER RATE IMPROVES. TO DATE, THE CUSTOMER HAS NOT SEEN AN IMPROVEMENT IN THE CEA RESULTS. SIEMENS REVIEWED THE MAINDATABASE FILE FROM THE IMMULITE 2000 XPI S/N (B)(6) AND THIS DID NOT SHOW A DIFFERENCE IN FLYER RATE FROM (B)(6) 2023. SIEMENS HAS MADE ADDITIONAL RECOMMENDATIONS AND IS AWAITING THE CUSTOMER'S RESPONSE.

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 2432235-2023-00158 ON JUNE 14, 2023. SIEMENS FILED THE MDR 2432235-2023-00158 SUPPLEMENTAL REPORT 1 ON JULY 07, 2023. SIEMENS FILED THE MDR 2432235-2023-00158 SUPPLEMENTAL REPORT 2 ON DECEMBER 08, 2023. SIEMENS FILED THE MDR 2432235-2023-00158 SUPPLEMENTAL REPORT 3 ON JANUARY 16, 2024. AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER TO REPORT A FALSELY ELEVATED CEA RESULT THAT WAS OBTAINED ON A SAMPLE FROM ONE PATIENT ON AN IMMULITE 2000 XPI INSTRUMENT AND CONSIDERED DISCORDANT WITH THE LOWER REPEAT RESULT. ON FEBRUARY 15, 2024, ADDITIONAL INFORMATION: THE CUSTOMER FRONT LOADED THE PATIENT SAMPLES LIKE THE QUALITY CONTROL. HOWEVER, NONREPEATABLE ELEVATED CEA RESULTS STILL OCCURRED. THE CUSTOMER WAS NOT WILLING TO TRY USING A DIFFERENT TYPE OF BLOOD DRAW TUBE (E.G. HAVE AN EXTRA TUBE DRAWN IN A DIFFERENT TYPE OF TUBE) TO SEE IF THE ISSUE OCCURS WITH A DIFFERENT TYPE OF TUBE. THE MOST LIKELY CAUSE FOR THE NONREPEATABLE ELEVATED CEA RESULTS IS SAMPLE INTEGRITY. SIEMENS IS AWAITING A RESPONSE FROM THE CUSTOMER.

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 2432235-2023-00158 ON JUNE 14, 2023. SIEMENS FILED THE MDR 2432235-2023-00158 SUPPLEMENTAL REPORT 1 ON JULY 07, 2023. SIEMENS FILED THE MDR 2432235-2023-00158 SUPPLEMENTAL REPORT 1 ON DECEMBER 08, 2023. AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER TO REPORT A FALSELY ELEVATED CEA RESULT THAT WAS OBTAINED ON A SAMPLE FROM ONE PATIENT ON AN IMMULITE 2000 XPI INSTRUMENT AND CONSIDERED DISCORDANT WITH THE LOWER REPEAT RESULT. DECEMBER 21, 2023 ADDITIONAL INFORMATION: THE CUSTOMER IS NOT SEEING THE SAME ISSUE WITH CONTROLS AS WITH PATIENT SAMPLES. BASED ON INFORMATION PREVIOUSLY PROVIDED ONE OF THE DIFFERENCES BETWEEN CONTROLS AND PATIENT SAMPLES AT THE CUSTOMER SITE IS THAT CONTROLS ARE FRONT LOADED WHILE PATIENT SAMPLES ARE NOT. SIEMENS HAS MADE ADDITIONAL RECOMMENDATIONS AND IS AWAITING THE CUSTOMER'S RESPONSE.

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 2432235-2023-00158 ON JUNE 14, 2023. SIEMENS FILED THE MDR 2432235-2023-00158 SUPPLEMENTAL REPORT 1 ON JULY 07, 2023. SIEMENS FILED THE MDR 2432235-2023-00158 SUPPLEMENTAL REPORT 2 ON DECEMBER 08, 2023. SIEMENS FILED THE MDR 2432235-2023-00158 SUPPLEMENTAL REPORT 3 ON JANUARY 16, 2024. SIEMENS FILED THE MDR 2432235-2023-00158 SUPPLEMENTAL REPORT 4 ON MARCH 6, 2024. SIEMENS FILED THE MDR 2432235-2023-00158 SUPPLEMENTAL REPORT 5 ON APRIL 11, 2024. AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER TO REPORT A FALSELY ELEVATED CEA RESULT THAT WAS OBTAINED ON A SAMPLE FROM ONE PATIENT ON AN IMMULITE 2000 XPI INSTRUMENT AND CONSIDERED DISCORDANT WITH THE LOWER REPEAT RESULT. ADDITIONAL INFORMATION RECEIVED ON JULY 8, 2024: THE CUSTOMER PLANS TO PERFORM THE STUDY USING DIFFERENT TYPES OF BLOOD DRAW TUBES DURING THE LAST WEEK OF (B)(6) 2024.

Additional Manufacturer Narrative

AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER TO REPORT A FALSELY ELEVATED CEA RESULT THAT WAS OBTAINED ON A SAMPLE FROM ONE PATIENT ON AN IMMULITE 2000 XPI INSTRUMENT AND CONSIDERED DISCORDANT WITH THE LOWER REPEAT RESULT. THE IFU STATES IN THE LIMITATIONS SECTION: "PATIENTS WITH CONFIRMED CARCINOMA OFTEN HAVE PRETREATMENT CEA LEVELS IN THE SAME RANGE AS HEALTHY PERSONS. ELEVATED CEA LEVELS ARE FREQUENTLY OBSERVED IN SMOKERS, IN CANCER PATIENTS AND IN PATIENTS WITH A VARIETY OF NONMALIGNANT DISEASES AND INFLAMMATORY CONDITIONS. THEREFORE, A SERUM CEA LEVEL, REGARDLESS OF ITS VALUE, SHOULD NOT BE INTERPRETED AS ABSOLUTE EVIDENCE FOR THE PRESENCE OR ABSENCE OF MALIGNANT DISEASE. THE CEA VALUE SHOULD BE USED IN CONJUNCTION WITH INFORMATION AVAILABLE FROM CLINICAL EVALUATION AND OTHER DIAGNOSTIC PROCEDURES. THE IMMULITE 2000 CEA ASSAY SHOULD NOT BE USED AS A CANCER SCREENING TEST." SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING.

Description of Event or Problem

A FALSELY ELEVATED CEA (CARCINOEMBRYONIC ANTIGEN) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT AND CONSIDERED DISCORDANT WITH THE LOWER REPEAT RESULT. IT IS UNKNOWN IF THE ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED CEA RESULT.

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 2432235-2023-00158 ON JUNE 14, 2023. SIEMENS FILED THE MDR 2432235-2023-00158 SUPPLEMENTAL REPORT 1 ON JULY 07, 2023. SIEMENS FILED THE MDR 2432235-2023-00158 SUPPLEMENTAL REPORT 2 ON DECEMBER 08, 2023. SIEMENS FILED THE MDR 2432235-2023-00158 SUPPLEMENTAL REPORT 3 ON JANUARY 16, 2024. SIEMENS FILED THE MDR 2432235-2023-00158 SUPPLEMENTAL REPORT 4 ON MARCH 6, 2024. AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER TO REPORT A FALSELY ELEVATED CEA RESULT THAT WAS OBTAINED ON A SAMPLE FROM ONE PATIENT ON AN IMMULITE 2000 XPI INSTRUMENT AND CONSIDERED DISCORDANT WITH THE LOWER REPEAT RESULT. MARCH 14, 2024 ADDITIONAL INFORMATION: THE CUSTOMER HAS AGREED TO TEST CEA SAMPLES USING TWO DIFFERENT TYPES OF BLOOD DRAW TUBES RUN IN PARALLEL. SIEMENS IS WAITING FOR THE UPDATE FROM THE CUSTOMER.

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 2432235-2023-00158 ON JUNE 14, 2023. SIEMENS FILED THE MDR 2432235-2023-00158 SUPPLEMENTAL REPORT 1 ON JULY 07, 2023. SIEMENS FILED THE MDR 2432235-2023-00158 SUPPLEMENTAL REPORT 2 ON DECEMBER 08, 2023. SIEMENS FILED THE MDR 2432235-2023-00158 SUPPLEMENTAL REPORT 3 ON JANUARY 16, 2024. SIEMENS FILED THE MDR 2432235-2023-00158 SUPPLEMENTAL REPORT 4 ON MARCH 6, 2024. SIEMENS FILED THE MDR 2432235-2023-00158 SUPPLEMENTAL REPORT 5 ON APRIL 11, 2024. SIEMENS FILED THE MDR 2432235-2023-00158 SUPPLEMENTAL REPORT 6 ON JULY 24, 2024. AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER TO REPORT A FALSELY ELEVATED CEA RESULT THAT WAS OBTAINED ON A SAMPLE FROM ONE PATIENT ON AN IMMULITE 2000 XPI INSTRUMENT AND CONSIDERED DISCORDANT WITH THE LOWER REPEAT RESULT. OCTOBER 11, 2024, ADDITIONAL INFORMATION: SIEMENS HAS COMPLETED THE INVESTIGATION. IN SUMMARY: CUSTOMER DATA FROM 2022 SHOWED THE ISSUE OCCURS WITH 1% OF CEA PATIENT SAMPLES AT THE CUSTOMER SITE AND IS SPORADIC IN ITS OCCURRENCE. CUSTOMER DATA FROM 2022 SHOWED THE ISSUE DOES NOT OCCUR WITH CEA QC AND THUS RULES OUT ASSAY COMPONENT SPECIFIC CAUSES SUCH AS BEAD EFFECTS. SIEMENS RULED OUT SAMPLE CARRYOVER AS A CAUSE. THE ISSUE IS NOT OBSERVED IN SIEMENS INTERNAL DATA; ASSAY PRECISION WAS ACCEPTABLE. SIEMENS TESTED 20 CUSTOMER SAMPLES AND 5 SIEMENS SOURCED NORMAL SAMPLES. ALL SAMPLES TESTED 10 TIMES WITH LOT 365, NO NON-REPEATABLE ELEVATED CEA RESULTS WERE OBSERVED. THE ISSUE COULD NOT BE REPLICATED. THE CUSTOMER HAS PROVIDED THE DATA FROM THE TUBE TYPE STUDY AND THE FLYER RATE FOR EACH TUBE TYPE WAS 0.2%. THE CUSTOMER PROCESSED SAMPLES USING THE SAME CEA REAGENT ON THE SAME ANALYZER AND OBTAINED A DISCORDANT RATE OF >0.5% WHICH IS GREATER THAN 0.2% FROM THE TUBE TYPE STUDY. BASED ON THE AVAILABLE INFORMATION THE CAUSE OF THE DISCORDANT RESULTS COULD NOT BE DETERMINED. A PRODUCT PROBLEM HAS NOT BEEN IDENTIFIED. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. IN SECTION H6, THE INVESTIGATION FINDING AND INVESTIGATION CONCLUSION CODES WERE UPDATED.