ATELLICA IM VITAMIN B12 (VB12)

Description of Event or Problem

THE CUSTOMER OBTAINED A DISCORDANT ELEVATED VITAMIN B12 (VB12) PATIENT RESULT USING REAGENT LOT 299 ON ATELLICA IM ANALYZER # (B)(6). THE PATIENT SAMPLE DISCORDANCE WAS IDENTIFIED AFTER (MOVING AVERAGE VIOLATION) UNSATISFACTORY VALUES FOR CUSTOMER METRICS (MOVING AVERAGE VIOLATION) WAS OBSERVED AND THE PATIENT SAMPLE WAS RETESTED ON DIFFERENT ATELLICA IM ANALYZER. NO CALIBRATION ISSUES WERE IDENTIFIED. THERE IS NO REPORT OF PHYSICIANS QUESTIONING RESULTS. THERE IS NO ALLEGATION OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THIS EVENT.

Additional Manufacturer Narrative

THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES (OUS). THE OUS CUSTOMER OBTAINED A DISCORDANT ELEVATED VITAMIN B12 (VB12) PATIENT RESULT USING REAGENT LOT 299 ON ATELLICA IM ANALYZER # (B)(6). THE PATIENT SAMPLE DISCORDANCE WAS IDENTIFIED AFTER (MOVING AVERAGE VIOLATION) UNSATISFACTORY VALUES FOR CUSTOMER METRICS (MOVING AVERAGE VIOLATION) WAS OBSERVED AND THE PATIENT SAMPLE WAS RETESTED ON DIFFERENT ATELLICA IM ANALYZER. NO CALIBRATION ISSUES WERE IDENTIFIED. THERE IS NO REPORT OF PHYSICIANS QUESTIONING RESULTS. THERE IS NO ALLEGATION OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THIS EVENT. CUSTOMER INVESTIGATION REVEALED THAT ALL SAMPLES WERE PROCESSED IN THE SAME ANCILLARY PACK AND SUSPECT N ANCILLARY PACK ISSUES. THE LOCAL TEAM DID NOT IDENTIFY ANY MECHANICAL ISSUES WITH THE ANALYZER. 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.

Additional Manufacturer Narrative

SIEMENS FILED MDR 1219913-2025-00160 INITIAL REPORT ON 22-AUG-2025. SIEMENS INVESTIGATED AN OUTSIDE THE UNITED STATES (OUS) CUSTOMER REPORT OF A DISCORDANT ELEVATED PATIENT RESULT USING REAGENT LOT 299 ON ATELLICA IM ANALYZER # IH00292. THE PATIENT SAMPLE DISCORDANCE WAS IDENTIFIED AFTER (MOVING AVERAGE VIOLATION) UNSATISFACTORY VALUES FOR CUSTOMER METRICS (MOVING AVERAGE VIOLATION) WAS OBSERVED AND PATIENT SAMPLES WERE RETESTED ON A DIFFERENT ATELLICA IM ANALYZER. NO MECHANICAL ISSUES WITH THE ANALYZER WERE IDENTIFIED. CALIBRATION RECORDS CONFIRMED VALID CALIBRATIONS FOR THE VB12 ASSAY. THE CUSTOMER DID NOT RUN QUALITY CONTROL (QC) ON THE PRIMARY REAGENT AND ANCILLARY PACK COMBINATION THAT WAS USED FOR PATIENT TESTING ON THE DAY OF EVENT. MULTIPLE PACKS OF BOTH PRIMARY AND ANCILLARY REAGENTS WERE CONCURRENTLY IN USE ON THE ATELLICA IM ANALYZER DURING THE TIME OF PATIENT AND QC TESTING MAKING IT DIFFICULT TO EVALUATE QC PERFORMANCE FOR THE NUMEROUS COMBINATIONS OF PRIMARY AND ANCILLARY PACK REAGENTS. SUBSEQUENT TESTING PRODUCED ON ALTERNATE PRIMARY AND ANCILLARY PACK PRODUCED ACCEPTABLE RESULTS. NO OTHER ISSUES WERE REPORTED WITH THE VB12 ASSAY. RETURN OF THE PATIENT SAMPLE FOR FURTHER INVESTIGATION IS NOT WARRANTED BECAUSE REPORTED DISCORDANT RESULT WAS NOT REPRODUCIBLE. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE DISCORDANT RESULT CANNOT BE DETERMINED DUE TO NO QC BEING PERFORMED ON THE VB12 PRIMARY READY PACK OR ANCILLARY PACK, BUT IT APPEARS TO BE AN ISOLATED ISSUE. THE CUSTOMER IS OPERATIONAL, AND THE REPORTED ISSUE IS RESOLVED BY ROUTINE TROUBLESHOOTING. IN SECTION H6 OF THIS REPORT, THE INVESTIGATION FINDING AND CONCLUSION CODES WERE UPDATED BASED ON THE INVESTIGATION RESULTS.