ATELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA)

Additional Manufacturer Narrative

AN OUTSIDE THE UNITED STATES CUSTOMER OBSERVED A FALSELY DEPRESSED ATELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA) RESULT FROM A PATIENT SAMPLE WHEN COMAPRED TO A PREVIOUS RESULT. THE IFU STATES IN THE INTERPRETATION OF RESULTS SECTION: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS." SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING.

Description of Event or Problem

THE CUSTOMER OBTAINED A DISCORDANT FALSELY DEPRESSED CARCINOEMBRYONIC ANTIGEN (CEA) RESULT FOR A PATIENT SAMPLE ON AN ATELLICA IM ANALYZER (B)(4) WHEN COMPARED TO A PREVIOUS HIGHER RESULT FROM (B)(6) 2022. THE PATIENT SAMPLE WAS REPEATED ON THE ORIGINAL AND ALTERNATE (B)(4) ATELLICA IM ANALYZERS. THE RESULTS FROM THE ORIGINAL ATELLICA IM ANALYZER SHOWED DISCORDANCY BETWEEN RESULTS. THE RESULT FROM THE ALTERNATE ATELLICA IM ANALYZER WAS HIGHER THAN THE INITIAL DEPRESSED RESULT AND SIMILAR TO THE PREVIOUS RESULT FROM (B)(6) 2022. THE INITIAL CEA RESULT WAS NOT REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CEA RESULTS.

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR ON 04-APR-2022. AN OUTSIDE THE UNITED STATES CUSTOMER OBSERVED TWO FALSELY DEPRESSED ATELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA) RESULTS FROM A PATIENT SAMPLE WHEN COMPARED TO A PREVIOUS RESULT. 04-APR-2022 CORRECTION: THIS IS A CORRECTION TO SECTION H4 OF THE INITIAL MDR. THE INITIAL MDR HAD THE INCORRECT YEAR FOR THE DEVICE MANUFACTURE DATE. THE DEVICE MANUFACTURE DATE IS 13-JUN-2021. SECTION H4 WAS UPDATED WITH THE INFORMATION. 12-APR-2022 ADDITIONAL INFORMATION: THE RESULT OF 134.3 NG/ML WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THE CUSTOMER TESTED THE PATIENT SAMPLE WITH THE 1/5 DILUTION FACTOR. THE RESULTS ARE AS FOLLOWS: ATELLICA IM S/N (B)(6) RESULT: 145 NG/ML. ATELLICA IM S/N (B)(6) RESULT: 140 NG/ML. SIEMENS HEALTHCARE DIAGNOSTICS CONTINUES TO INVESTIGATE.

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 1219913-2022-00099 ON 04-APR-2022. SIEMENS FILED THE MDR 1219913-2022-00099 SUPPLEMENTAL REPORT 1 ON 28-APR-2022. 05-MAY-2022 ADDITIONAL INFORMATION: AN OUTSIDE THE UNITED STATES CUSTOMER OBSERVED TWO FALSELY DEPRESSED ATELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA) RESULTS FROM A PATIENT SAMPLE WHEN COMPARED TO A PREVIOUS RESULT. SIEMENS REVIEWED THE CALIBRATION, CONTROL (QC), AND PATIENT DATA PROVIDED. THE CUSTOMER USED A 1/50 DILUTION WHEN THE RESULT OF 139.4 WAS OBTAINED AS STATED IN THE INITIAL MDR. THE CUSTOMER THEN TESTED THE PATIENT SAMPLE WITH THE 1/5 DILUTION FACTOR AS STATED IN THE 1ST MDR SUPPLEMENTAL REPORT AND THE RESULTS WERE 145 NG/ML AND 140 NG/ML. THEREFORE, THE RESULT WITH THE 1/50 DILUTION WAS NOT DUE TO OVERDILUTION. THE HIGH QUALITY CONTROL (QC) 99633T RECOVERED 36.72 AND 36.84 NG/ML (8% BELOW TARGET, 39.9 NG/ML) ON ATELLICA IM S/N (B)(6) WITH THE SAME REAGENT PACK AND THE SAME CALIBRATION USED TO GENERATE THE PATIENT SAMPLE RESULTS. THE 95.31 NG/ML VALUE WAS ONLY 5% BELOW THE TOP OF THE ASSAY RANGE (100 NG/ML) SO RECOVERING 8% LOW COULD HAVE CAUSE THE UNDILUTED SAMPLE TO RECOVER ON CURVE. THE DILUTION RECOVERY SECTION IN ATELLICA IM CEA INSTRUCTIONS FOR USE (IFU) (10995312) INDICATES RECOVERY RANGE FROM 108.6% - 139.8% WITH A MEAN OF 123.4%, SO HIGH RECOVERY WITH DILUTIONS IS TO BE EXPECTED. THE CAUSE OF THE DIFFERENCE IN RESULTS SEEN BY THE CUSTOMER WHEN TESTING THIS ONE SAMPLE WITH ATELLICA IM CEA ASSAY LOT 208 COULD NOT BE DETERMINED BUT SIEMENS CANNOT RULE OUT PRE-ANALYTICAL FACTORS, A SAMPLE ISSUE, OR NORMAL ASSAY PERFORMANCE. BASED ON THE INVESTIGATION, NO PRODUCT PROBLEM WAS IDENTIFIED. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. IN SECTION H6, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSION CODES WERE UPDATED BASED ON THE INVESTIGATION RESULTS.