ATELLICA IM VITAMIN B12 (VB12)

Description of Event or Problem

THE CUSTOMER REPORTS AN OBSERVATION OF AN ELEVATED ATELLICA IM VITAMIN B12 (VB12) WHICH WAS CONSIDERED DISCORDANT WHEN USING REAGENT LOT# 296. AN INITIAL ELEVATED VB12 RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. HOWEVER, THE CUSTOMER DID NOT REPEAT TEST THE SAMPLE AND THE CORRECT RESULT IS UNKNOWN. THERE ARE NO KNOWN REPORTS OF DELAY, PATIENT INTERVENTION, OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

Additional Manufacturer Narrative

A CUSTOMER FROM OUTSIDE THE UNITED STATES (OUS) REPORTED AN OBSERVATION OF AN ELEVATED ATELLICA IM VITAMIN B12 (VB12) RESULT WHICH WAS CONSIDERED DISCORDANT. 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 THE ISSUE.

Additional Manufacturer Narrative

MDR 1219913-2025-00088 WAS INITIALLY FILED ON 25-APR-2025. ADDITIONAL INFORMATION (28-MAY-2025): SIEMENS HEALTHCARE DIAGNOSTICS HAS CONCLUDED THE INVESTIGATION OF THE EVENT. A CUSTOMER FROM OUTSIDE THE UNITED STATES (OUS) REPORTED AN OBSERVATION OF AN ELEVATED ATELLICA IM VITAMIN B12 (VB12) RESULT (HIGHER THAN THE UPPER LIMIT OF THE NORMAL RANGE), WHICH WAS CONSIDERED DISCORDANT. SIEMENS EVALUATED THE INSTRUMENT DATA, AND THE INFORMATION PROVIDED BY THE CUSTOMER. SIEMENS REVIEWED THE GLOBAL CUSTOMER DATA FOR THE ATELLICA IM VB12 ASSAY TO ASSESS THE PERCENTAGE FREQUENCY OF RESULTS FALLING BELOW AND ABOVE 911 PG/ML. REAGENT LOTS 291 AND 295, WHICH WERE USED BY THE CUSTOMER IN THE COMPARISON STUDY, WERE ANALYZED AND DEMONSTRATED A 1% VARIATION IN RESULT FREQUENCY ACROSS DOSE RANGES. ACCORDING TO THE ATELLICA IM VITAMIN B12 INSTRUCTIONS FOR USE (IFU), NO PEDIATRIC REFERENCE RANGES ARE CURRENTLY ESTABLISHED FOR THIS ASSAY. THE CUSTOMER HAS SINCE TRANSITIONED TO USING REAGENT LOT 297 WITH CALIBRATOR CC83 AND HAS REPORTED ACCEPTABLE PATIENT RESULTS AND ASSAY PERFORMANCE. REAGENT ISSUES WERE RULED OUT BASED ON REVIEW OF QUALITY CONTROL (QC), WHICH SHOWED RECOVERY WITHIN THE ACCEPTABLE RANGES. CALIBRATION DATA SHOWED VALID CALIBRATION FOR THE VB12 ASSAY. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE DISCORDANT RESULT CANNOT BE DETERMINED. A PRODUCT PROBLEM HAS NOT BEEN IDENTIFIED. THE CUSTOMER IS OPERATIONAL, AND THE REPORTED ISSUE WAS RESOLVED BY ROUTINE TROUBLESHOOTING. NOTE: IN SECTION H6, THE CODES FOR INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS HAVE BEEN UPDATED.