ATELLICA IM VITAMIN B12 (VB12)

Additional Manufacturer Narrative

A UNITED STATES CUSTOMER REPORTED OBSERVATION OF AN ATELLICA IM VITAMIN B12 (VB12) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. MDR 1219913-2025-00093 WAS INITIALLY SUBMITTED ON 07-MAY-2025. UPDATE, 15-MAY-2025: SIEMENS HAS CONCLUDED INVESTIGATION. REVIEW OF CUSTOMER QUALITY CONTROL (QC) RESULTS FOR VB12 SHOWED THAT QC WAS OUT OF RANGE FOR ALL THREE LEVELS. VB12 PATIENT TESTING WAS NOT HALTED WHEN THE FAILING QC RESULTS WERE PRODUCED. THE CUSTOMER RESOLVED THEIR OUT-OF-RANGE QC ISSUE BY RECALIBRATING THE ASSAY, AND SUBSEQUENT TESTING WAS WITHOUT ISSUE. RETURN OF THE AFFECTED SAMPLE FOR FURTHER INVESTIGATION IS NOT WARRANTED AS THE DISCORDANT RESULT WAS NOT REPRODUCIBLE. ALTHOUGH A SPECIFIC CAUSE FOR THE DISCORDANT RESULT COULD NOT BE IDENTIFIED, NO SYSTEMIC PRODUCT PROBLEM WAS FOUND. THE CUSTOMER IS OPERATIONAL, AND THE OBSERVED ISSUE WAS RESOLVED BY RECALIBRATING THE ASSAY. NOTE: IN SECTION H6, THE CODES FOR INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS HAVE BEEN UPDATED.

Additional Manufacturer Narrative

A UNITED STATES CUSTOMER REPORTED OBSERVATION OF ATELLICA IM VITAMIN B12 (VB12) RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING. 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.

Description of Event or Problem

THE CUSTOMER REPORTS OBSERVATION OF AN ATELLICA IM VITAMIN B12 (VB12) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING VB12 LOT 299. THE CUSTOMER IDENTIFIED A QC FAILURE FOR VB12, AND REPEAT-TESTED SAMPLES FOR WHICH INITIAL RESULTS HAD BEEN REPORTED. FOR ONE SAMPLE, THE INITIAL RESULT WAS MUCH HIGHER THAN THE REPEAT RESULT, AND THE REPEAT RESULT WAS CONSIDERED CORRECT. THERE WAS NO MEDICAL INTERVENTION PERFORMED ON THE BASIS OF THE INITIAL RESULT. THERE ARE NO REPORTS OF PATIENT HARM OR ANY OTHER ADVERSE CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED ISSUE.