MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA); SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN

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	03/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported observation of an elevated atellica im carcinoembryonic antigen (cea) result which was discordant relative to repeat testing when using cea lot 223.Repeat testing produced acceptable results.Quality control (qc) results on the day of the event were within expected ranges.Siemens is investigating.
Event or Problem Description
The customer reports observation of an elevated atellica im carcinoembryonic antigen (cea) result which was discordant relative to repeat testing when using cea lot 223.An initial atellica im cea result disagreed with lower results obtained in repeat testing using both the initial instrument and an alternate atellica im analyzer.There are no allegations of any adverse patient consequences in association with the discordant observation.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of an elevated atellica im carcinoembryonic antigen (cea) result which was discordant relative to repeat testing.Mdr 1219913-2025-00067 was initially submitted on 01-apr-2025.Update, 13-may-2025: siemens has concluded the investigation.General reagent issues were ruled out as quality control (qc) results were within expected ranges and no issues were identified for any other samples.Based on siemens review of instrument log details, sample-probe alignment was performed according to standard service guidelines.Following instrument service, the system was checked and no more issues were observed.Although a specific cause for the discordant result was not identified, no systemic product problems were identified.The customer is operational, and the reported issue is resolved by routine service activities.Note: in section h6, the codes for investigation findings and investigation conclusions have been updated.

• Brand Name: ATELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA)
• Common Device Name: SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
• 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: 21750842
• Report Number: 1219913-2025-00067
• Device Sequence Number: 18197905
• Product Code: DHX
• UDI-Device Identifier: 00630414598505
• UDI-Public: (01)00630414598505(10)69173223(17)251120
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K200215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

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: 11/20/2025
• Device Model Number: N/A
• Device Catalogue Number: 10995523
• Device Lot Number: 69173223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2024
• 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