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	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer reported observation of elevated atellica im vitamin b12 (vb12) results which were discordant relative to repeat testing.Siemens evaluated the instrument data and the information provided by the customer.Reagent and instrument issues were ruled out based on quality control (qc) recovery within acceptable ranges, and no issues were reported with other patient samples.Siemens noted that the analyzer generated volume check errors on reagent probe 1 which was associated with ancillary pack (b)(6).Following this, the customer confirmed that an incorrect volume of releasing agent (4ml instead of 12 ml) was used during manual preparation of the vb12 dtt ancillary reagent.Siemens further evaluated the event and determined that the initial discordant results were obtained due to insufficient reagent volume, which was consistent with the preparation error.After introducing a freshly prepared and correctly measured vb12 ancillary reagent, the reported issue was resolved.Return of the patient sample for further investigation is not warranted because the discordant result was not reproducible.Per the assay's instructions for use (ifu), under section preparing the reagents, the following instruction is provided: "add 300 l dtt to 12.0 ml releasing agent in a test tube using a volumetric pipet." based on the available information, the discordant results are attributed to the customer's failure to follow the provided instructions.The issue was resolved by routine troubleshooting; a product problem was not identified.The customer is operational, and no further actions are required.
Event or Problem Description
The customer reported observation of elevated atellica im vitamin b12 (vb12) results which were discordant relative to repeat testing when using reagent lot # 299.Initial elevated vitamin b12 (vb12) results were obtained two patient samples.The elevated results were reported to the physician(s), who did not question the results.However, the same samples were repeated on the original analyzer because the customer indicated that the vb12 ancillary reagent was improperly prepared; instead of the required 12 ml of releasing agent, only 4 ml was used.The repeat results recovered lower, which were considered correct, and corrected reports were issued to the physician(s).There are no known reports of patient intervention or adverse health consequences due to this event.

• 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: 22780537
• Report Number: 1219913-2025-00156
• Device Sequence Number: 10045584
• Product Code: CDD
• UDI-Device Identifier: 00630414600277
• UDI-Public: (01)00630414600277(10)86080299(17)251207
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/12/2025

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: 10995714
• Device Lot Number: 86080299
• 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: 07/17/2025
• Initial Report FDA Received Date: 08/12/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown