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	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports observation of depressed atellica im carcinoembryonic antigen (cea) results which were discordant relative to repeat testing when using cea lot 226.The customer indicates that some samples have produced falsely-depressed atellica im cea results which disagreed with higher results produced upon repeat testing using the same instrument.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 depressed atellica im carcinoembryonic antigen (cea) results which were discordant relative to repeat testing.Siemens is investigating.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of depressed atellica im carcinoembryonic antigen (cea) results which were discordant relative to repeat testing.Update, 03-mar-2026: siemens has concluded the investigation.The customer reported that three samples had produced falsely depressed results (<0.5 ng/ml) which conflicted with higher results obtained from repeat testing on the same instrument.However, siemens has been unable to identify the erroneous results described.The repeat tests, identified as correct, can be seen in the instrument¿s record from (b)(6) 2026.The initial results for these samples, which the customer indicates were <0.5 ng/ml, are not present in the instrument record any time after (b)(6) 2026.All assay quality control (qc) results were within specified ranges for the period from (b)(6) 2026.Reagent-related causes were effectively ruled out based on observed qc results and the absence of issues for any other samples.Return of the affected samples for further investigation was not possible due to unavailability of sample.Due to the lack of available information, the alleged erroneous results cannot be investigated further, and the cause for the discordant results cannot be determined.There is no evidence of a systemic reagent or instrument-related cause.The customer is operational with the cea assay and continues to monitor qc and patient results.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 02053
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 24162041
• Report Number: 1219913-2026-00023
• Device Sequence Number: 15731507
• Product Code: DHX
• UDI-Device Identifier: 00630414598512
• UDI-Public: (01)00630414598512(10)91462226(17)260904
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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: 09/04/2026
• Device Model Number: N/A
• Device Catalogue Number: 10995524
• Device Lot Number: 91462226
• 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: 01/17/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2025
• 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