MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM VITAMIN B12 (VB12)

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported observation of an elevated atellica im vitamin b12 (vb12) result which was discordant relative to repeat testing when using reagent lot# 299.An initial elevated vb12 result was obtained for the patient in question.The elevated result was reported to the physician(s), who did not question the result.The same sample was repeated on an alternate atellica im analyzer and obtained a lower result, which was considered correct and issued on the corrected report to the physician(s).There are no known reports of patient intervention or adverse health consequences due to this event.
Additional Manufacturer Narrative
An outside of united states (ous) customer contacted the siemens remote services center (rsc) and reported observation of an elevated atellica im vitamin b12 (vb12) result which was discordant relative to repeat testing.Siemens evaluated the instrument, calibration, and quality control (qc) data provided by the customer.Qc results were out-of-range on the event date following patient sample processing, although calibration remained valid.Siemens was unable to verify the performance of the vb12 reagent packs due to the concurrent use of multiple primary and ancillary reagent packs during their onboard stability period.Discordant results were observed in only a few samples; however, multiple other patient samples tested before and after, using the same reagent and ancillary packs, produced consistent results without system errors.The customer replaced both the primary and ancillary reagent packs in question with alternative vb12 reagent and ancillary packs, and no further issues were reported.Siemens further evaluated the event and determined that discordant results may occur due to improper mixing, delays before use, or incorrect volumes during manual preparation of the dtt reagent.The user was recommended to review the proper preparation and handling procedures for the dtt/releasing agent as outlined in the atellica im vb12 instructions for use (ifu), under the section "preparing the reagents." return of the patient sample for further investigation is not warranted because the discordant result was not reproducible.Based on the available information, the cause of the discordant 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.

• Brand Name: ATELLICA IM VITAMIN B12 (VB12)
• Common Device Name: ATELLICA IM VITAMIN B12 (VB12)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; registration# 1219913; east walpole MA 02032
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 22296381
• Report Number: 1219913-2025-00120
• Device Sequence Number: 18373183
• Product Code: CDD
• UDI-Device Identifier: 00630414600284
• UDI-Public: (01)00630414600284(10)83769299(17)251207
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K993571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/07/2025
• Device Model Number: N/A
• Device Catalogue Number: 10995715
• Device Lot Number: 83769299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Sex: Female