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	02/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states (ous) reported an observation of an elevated atellica im vitamin b12 (vb12) result which was considered discordant.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 the issue.
Event or Problem Description
The customer reports an observation of an elevated atellica im vitamin b12 (vb12) which was considered discordant when using reagent lot# 296.An initial elevated vb12 result was obtained for a patient sample.The elevated result was reported to the physician(s), who questioned the result.However, the customer did not repeat test the sample and the correct result is unknown.There are no known reports of delay, patient intervention, or adverse health consequences due to this event.
Additional Manufacturer Narrative
Mdr 1219913-2025-00087 was initially filed on 25-apr-2025.Additional information (28-may-2025): siemens healthcare diagnostics has concluded the investigation of the event.A customer from outside the united states (ous) reported an observation of an elevated atellica im vitamin b12 (vb12) result (higher than the upper limit of the normal range), which was considered discordant.Siemens evaluated the instrument data, and the information provided by the customer.Siemens reviewed the global customer data for the atellica im vb12 assay to assess the percentage frequency of results falling below and above 911 pg/ml.Reagent lots 291 and 295, which were used by the customer in the comparison study, were analyzed and demonstrated a 1% variation in result frequency across dose ranges.According to the atellica im vitamin b12 instructions for use (ifu), no pediatric reference ranges are currently established for this assay.The customer has since transitioned to using reagent lot 297 with calibrator cc83 and has reported acceptable patient results and assay performance.Reagent issues were ruled out based on review of quality control (qc), which showed recovery within the acceptable ranges.Calibration data showed valid calibration for the vb12 assay.Based on the available information, the cause of the discordant result cannot be determined.A product problem has not been identified.The customer is operational, and the reported issue was resolved by routine troubleshooting.Note: in section h6, the 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: 21907376
• Report Number: 1219913-2025-00087
• Device Sequence Number: 4183913
• Product Code: CDD
• UDI-Device Identifier: 00630414600277
• UDI-Public: (01)00630414600277(10)10128296(17)250521
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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,Followup
• Report Date (Section B): 06/18/2025

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: 05/21/2025
• Device Model Number: N/A
• Device Catalogue Number: 10995714
• Device Lot Number: 10128296
• 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: 04/01/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2024
• 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 Age: 12 MO
• Patient Sex: Male