ATELLICA IM VITAMIN B12 (VB12)

Additional Manufacturer Narrative

SIEMENS FILED MDR 1219913-2025-00161 INITIAL REPORT ON 22-AUG-2025. SIEMENS COMPLETED INVESTIGATION FOR AN OUTSIDE THE UNITED STATES (OUS) CUSTOMER REPORT OF DISCORDANT ELEVATED VITAMIN B12 (VB12) PATIENT RESULTS USING REAGENT LOT 300 ON ATELLICA IM ANALYZER # IH02379. CALIBRATION RECORDS WERE REVIEWED AND WERE FOUND TO BE VALID. HOWEVER, AN INCREASE IN RELATIVE LIGHT UNITS (RLUS) WAS OBSERVED DURING THE 06 AUGUST CALIBRATION, WHICH INTRODUCED A NEGATIVE BIAS IN BOTH QUALITY CONTROL (QC) AND PATIENT RESULTS. MULTIPLE COMBINATIONS OF PRIMARY AND ANCILLARY REAGENT PACKS WERE IN USE CONCURRENTLY DURING PATIENT AND QC TESTING. THIS COMPLEXITY LIMITED THE ABILITY TO ISOLATE SPECIFIC REAGENT INTERACTIONS AND ASSESS QC PERFORMANCE EFFECTIVELY. QC RESULTS DURING THIS PERIOD WERE INCONSISTENT AND, AT TIMES, FELL BELOW ACCEPTABLE THRESHOLDS BASED ON THE CUSTOMER'S HISTORICAL QC DATA. A RECALIBRATION PERFORMED ON 07 AUGUST 2025 RESULTED IN ACCEPTABLE QC PERFORMANCE, AND NO FURTHER ANOMALIES WERE REPORTED WITH THE VB12 ASSAY THEREAFTER. NO CORRECTIVE MAINTENANCE WAS PERFORMED ON THE ANALYZER DURING THE RELEVANT TIMEFRAME, AND NO SYSTEM FLAGS OR ERRORS WERE RECORDED. RETURN OF THE ORIGINAL PATIENT SAMPLES FOR FURTHER ANALYSIS WAS DEEMED UNNECESSARY, AS THE DISCORDANT RESULTS WERE NOT REPRODUCIBLE UPON RETESTING. BASED ON THE AVAILABLE DATA, THE CAUSE OF THE DISCORDANT RESULTS COULD NOT BE DETERMINED. THE CUSTOMER IS OPERATIONAL, AND THE REPORTED ISSUE WAS RESOLVED BY ROUTINE RETESTING / TROUBLESHOOTING. IN SECTION H6 OF THIS REPORT, THE INVESTIGATION FINDING AND CONCLUSION CODES WERE UPDATED BASED ON THE INVESTIGATION RESULTS.

Description of Event or Problem

THE CUSTOMER REPORTS DISCORDANT ELEVATED VITAMIN B12 (VB12) PATIENT RESULTS USING REAGENT LOT 300 ON ATELLICA IM ANALYZER # (B)(6). THE DISCORDANCE WAS IDENTIFIED AFTER A QUALITY CONTROL MOVING AVERAGE VIOLATION (>2SD DEVIATION) WAS OBSERVED AND PATIENT SAMPLES WERE RETESTED ON DIFFERENT ATELLICA IM ANALYZERS. NO CALIBRATION ISSUES WERE IDENTIFIED. THERE IS NO REPORT OF PHYSICIANS QUESTIONING THE RESULTS. THERE ARE NO ALLEGATIONS 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 REPORTS DISCORDANT ELEVATED VITAMIN B12 (VB12) PATIENT RESULTS USING REAGENT LOT 300 ON ATELLICA IM ANALYZER # (B)(6). THE DISCORDANCE WAS IDENTIFIED AFTER A QUALITY CONTROL MOVING AVERAGE VIOLATION (>2SD DEVIATION) WAS OBSERVED AND PATIENT SAMPLES WERE RETESTED ON DIFFERENT ATELLICA IM ANALYZERS. 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. 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.