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

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	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer reported observation of atellica im vitamin b12 (vb12) results which were discordant relative to repeat testing.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.
Event or Problem Description
The customer reports observation of an atellica im vitamin b12 (vb12) result which was discordant relative to repeat testing when using vb12 lot 299.The customer identified a qc failure for vb12, and repeat-tested samples for which initial results had been reported.For one sample, the initial result was much higher than the repeat result, and the repeat result was considered correct.There was no medical intervention performed on the basis of the initial result.There are no reports of patient harm or any other adverse consequences in association with the observed issue.
Additional Manufacturer Narrative
A united states customer reported observation of an atellica im vitamin b12 (vb12) result which was discordant relative to repeat testing.Mdr 1219913-2025-00093 was initially submitted on 07-may-2025.Update, 15-may-2025: siemens has concluded investigation.Review of customer quality control (qc) results for vb12 showed that qc was out of range for all three levels.Vb12 patient testing was not halted when the failing qc results were produced.The customer resolved their out-of-range qc issue by recalibrating the assay, and subsequent testing was without issue.Return of the affected sample for further investigation is not warranted as the discordant result was not reproducible.Although a specific cause for the discordant result could not be identified, no systemic product problem was found.The customer is operational, and the observed issue was resolved by recalibrating the assay.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: RADIOASSAY, VITAMIN B12
• 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: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 21975808
• Report Number: 1219913-2025-00093
• Device Sequence Number: 9253110
• Product Code: CDD
• UDI-Device Identifier: 00630414600284
• UDI-Public: (01)00630414600284(10)83769299(17)251207
• 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,Followup
• Report Date (Section B): 05/15/2025

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: 05/02/2025
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 05/15/2025
• 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: A
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female