ATELLICA IM VITAMIN B12 (VB12)

Additional Manufacturer Narrative

MDR 1219913-2025-00091 WAS INITIALLY FILED ON 02-MAY-2025. ADDITIONAL INFORMATION (02-JUN-2025): SIEMENS HAS CONCLUDED THE INVESTIGATION FOR THE ISSUE REPORTED BY AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER REGARDING OBSERVATION OF AN ELEVATED ATELLICA IM VITAMIN B12 (VB12) RESULT WHICH WAS CONSIDERED DISCORDANT. SIEMENS EVALUATED THE INSTRUMENT DATA AND DATA PROVIDED BY THE CUSTOMER. REAGENT AND INSTRUMENT ISSUES WERE RULED OUT BASED ON QC RECOVERY WITHIN ACCEPTABLE RANGES, VALID CALIBRATION AND NO ISSUES WERE REPORTED WITH OTHER PATIENT SAMPLES. PER THE ASSAY'S INSTRUCTIONS FOR USE (IFU), THERE ARE NO PUBLISHED REFERENCE RANGES FOR PEDIATRIC POPULATION. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE ELEVATED RESULT WAS UNABLE TO BE DETERMINED. NO PRODUCT PROBLEM HAS 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.

Additional Manufacturer Narrative

A CUSTOMER FROM OUTSIDE THE UNITED STATES (OUS) REPORTED 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 EVALUATING THE EVENT.

Description of Event or Problem

THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM VITAMIN B12 (VB12) RESULT WHICH WAS CONSIDERED DISCORDANT WHEN USING REAGENT LOT# 297. AN INITIAL ELEVATED (>1000 PG/ML) RESULT WAS OBTAINED. 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 IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.