MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM; 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	12/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer reported an observation of elevated atellica im vitamin b12 (vb12) patient result for a sample, which was discordant relative to repeat testing.Siemens evaluated the instrument data, and the information provided by the customer.Siemens reviewed reagent and ancillary reagent usage related to the affected sample.Quality control (qc) results for the ancillary dilution tray turntable (dtt) packs and primary pack reagents were outside the customer-defined range on the day of the event.Subsequent testing using alternate primary and ancillary packs produced acceptable results, and no further vb12 assay issues were observed.Siemens further evaluated the event and determined that the calibration in use on the day of the event might have affected the vb12 result by creating a slight positive bias.After performing the new calibration, the vb12 result returned to the expected value.Return of the patient sample for additional investigation was not required because the discordant result was not reproducible.Based on the available information, the cause of the discordant vb12 result was unable to be determined.A product problem has not been identified.The customer is operational.
Event or Problem Description
The customer reported an observation of elevated atellica im vitamin b12 (vb12, lot# 302) patient result for a sample, which was discordant relative to repeat testing.The initial result was not reported to the physician(s).The sample was retested on an alternate atellica im 1600 analyzer, which yielded a lower result.The lower retested result was reported as the correct result to the physician(s).There are no known reports of patient intervention or adverse health consequences due to this event.

• Brand Name: ATELLICA IM
• 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: 24112767
• Report Number: 1219913-2026-00019
• Device Sequence Number: 5891144
• Product Code: CDD
• UDI-Device Identifier: 00630414600284
• UDI-Public: (01)00630414600284(10)79493302(17)260707
• 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): 01/20/2026

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: 07/07/2026
• Device Model Number: N/A
• Device Catalogue Number: 10995715
• Device Lot Number: 79493302
• 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: 12/26/2025
• Initial Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2025
• 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: 64 YR
• Patient Sex: Female