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	04/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from the united states (us) reported an observation of elevated atellica im vitamin b12 (vb12) results, which were considered discordant.Siemens is evaluating the event.
Event or Problem Description
The customer reports an observation of discordant elevated atellica im vitamin b12 (vb12, lot: 298) results on two patient samples on an atellica ci 1900 analyzer.The initial elevated results were not reported to the physician(s).The sample (b)(6) was repeated thrice on the same atellica ci 1900 analyzer.The results obtained were relatively lower, but the customer was unable to determine the correct result.The repeat results were not reported, and the customer stated that they will redraw the samples and retest for the correct result.For sample id: (b)(6), the customer did not perform any repeat testing, and the correct result is unknown.There are no known reports of patient intervention or adverse health consequences due to this event.
Additional Manufacturer Narrative
Mdr 1219913-2025-00104 was initially filed on 27-may-2025.Additional information (06-june-2025): siemens healthcare diagnostics has concluded the investigation of the event.A customer from outside the united states (ous) reported an observation of discordant elevated atellica im vitamin b12 (vb12) results on two patient samples which were considered discordant.Siemens evaluated the instrument data, and the information provided by the customer.Reagent issues were ruled out based on quality control (qc) and calibration data recovery within acceptable ranges, and no issues were reported with other patient samples.The customer did not test the affected patient samples for the presence of heterophilic antibodies (hbt or nabt).Additionally, the samples were not available for siemens' evaluation, as the customer was unable to obtain a redraw on time.As a result, siemens was unable to further investigate the issue.Based on the available information, the cause of the discordant results was due to sample integrity or quality issues, as demonstrated by the irregular patient results on repeat and expected assay performance with dilution.The issue was resolved by routine troubleshooting.A product problem has not been identified.The customer is operational and no further actions are required.Note: in section h6, codes for investigation findings and investigation conclusions have been updated.

• 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: 22086204
• Report Number: 1219913-2025-00104
• Device Sequence Number: 7866972
• Product Code: CDD
• UDI-Device Identifier: 00630414600277
• UDI-Public: (01)00630414600277(10)57260298(17)250929
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 06/27/2025

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: 09/29/2025
• Device Model Number: N/A
• Device Catalogue Number: 10995714
• Device Lot Number: 57260298
• 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: 05/02/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2024
• 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