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	07/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that erroneously elevated vitamin b12 (vb12) results were obtained on three patient samples when using reagent lot 300 on an atellica im 1300 analyzer.The initial results were reported to the physician(s), who questioned the results.The samples were not repeated because the samples were discarded by the time the physician called the lab.The customer confirmed that the patients were not redrawn.The correct results are unknown for these samples.There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated vb12 results.
Additional Manufacturer Narrative
A united states (us) customer reported that erroneously elevated vitamin b12 (vb12) results were obtained on three patient samples on an atellica im 1300 analyzer.Quality control (qc) and calibration were acceptable when the erroneous results were obtained.Siemens reviewed the instrument data and the information provided by the customer and ruled out reagent issues based on the review of qc which showed recovery within acceptable ranges and no issues were reported with other patient samples.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse performed a total service visit (tsv), and no issues were found that affected the assay or instrument's performance.Based on the available information, the cause of the discordant results was unable to be determined as repeat testing was not performed to verify assay performance.The issue was resolved by routine troubleshooting; a product problem was not identified.The customer is operational, and no further actions are required.

• 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: 22839205
• Report Number: 1219913-2025-00158
• Device Sequence Number: 21187967
• Product Code: CDD
• UDI-Device Identifier: 00630414600277
• UDI-Public: (01)00630414600277(10)20352300(17)260227
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2025

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: 02/27/2026
• Device Model Number: N/A
• Device Catalogue Number: 10995714
• Device Lot Number: 20352300
• 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: 07/25/2025
• Initial Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2025
• 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 Sex: Unknown