ATELLICA IM CA19-9 (CA 19-9)

Additional Manufacturer Narrative

AN OUTSIDE UNITED STATES (OUS) CUSTOMER IDENTIFIED DISCORDANT ATELLICA IM ATELLICA IM CA19-9 (CA 19-9) PATIENT RESULTS AFTER A QUALITY CONTROL (QC) ISSUE OCCURRED. AFTER THE QC ISSUE WAS IDENTIFIED, PATIENT SAMPLES PREVIOUSLY TESTED WERE RETESTED ON A DIFFERENT ATELLICA IM INSTRUMENT AND THE DISCORDANCE BETWEEN RESULTS WAS IDENTIFIED. THE COMPLAINT INDICATES THAT THE INITIAL RESULTS WERE REPORTED BUT NOT QUESTIONED BY PHYSICIANS AND THE RETEST RESULTS WERE REPORTED AS CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED CA 19-9 RESULTS. THE CUSTOMER REPLACED THE REAGENT PACK AND CALIBRATED THE ASSAY. THE CUSTOMER RAN QUALITY CONTROL (QC), WHICH RECOVERED IN RANGE. SIEMENS IS INVESTIGATING.

Description of Event or Problem

THE CUSTOMER IDENTIFIED DISCORDANT ATELLICA IM ATELLICA IM CA19-9 (CA 19-9) PATIENT RESULTS AFTER A QUALITY CONTROL (QC) ISSUE OCCURRED. AFTER THE QC ISSUE WAS IDENTIFIED, PATIENT SAMPLES PREVIOUSLY TESTED WERE RETESTED ON A DIFFERENT ATELLICA IM INSTRUMENT AND THE DISCORDANCE WAS IDENTIFIED. THE COMPLAINT INDICATES THAT THE INITIAL RESULTS WERE REPORTED BUT NOT QUESTIONED BY PHYSICIANS AND THE RETEST RESULTS WERE REPORTED AS CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED CA 19-9 RESULTS.

Additional Manufacturer Narrative

SIEMENS FILED MDR 1219913-2024-00499 INITIAL REPORT ON 12-DEC-2024. SIEMENS COMPLETED THE INVESTIGATION FOR A CUSTOMER REPORT OF ATELLICA IM CANCER ANTIGEN 19-9 (CA 19-9) LOT 541DISCORDANT PATIENT RESULTS ON ATELLICA IM SN# (B)(6) VS. REPEAT TESTING THAT WAS CONDUCTED DUE TO OUT-OF-RANGE QUALITY CONTROL (QC) RESULTS. THE SAMPLES WERE REPEATED ON AN ALTERNATE ATELLICA IM ANALYZER (SN# (B)(6). SIEMENS EVALUATED CUSTOMER DATA (CALIBRATION AND QC) AND EVALUATED SYSTEM FILES. BASED ON THE EVALUATION, SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE ACCOUNT TO PERFORM ROUTINE VACUUM AND FLUIDICS TROUBLESHOOTING, AS WELL, AS ACID DISPENSE. A REAGENT ISSUE WAS RULED OUT AS THE SOURCE OF THE PROBLEM. SIEMENS EVALUATED THE PRECISION PERFORMANCE OF CA 19-9 LOT 541 AFTER CONCLUSION OF SERVICE ACTIONS (ATELLICA IM SN# (B)(6); PRECISION PERFORMANCE WAS WITHIN EXPECTED RANGES. MEANWHILE, THE CUSTOMER CALIBRATED CA 19-9 LOT 545 AND IT IS SATISFIED WITH THE PERFORMANCE OF THE ASSAY. CUSTOMER DECLINED FURTHER TROUBLESHOOTING AND SIEMENS SUPPORT. BASED ON THE INFORMATION PROVIDED THE CAUSE OF THE NONREPEATABLE ELEVATED RESULTS COULD NOT BE DETERMINED. THE CUSTOMER IS OPERATIONAL.