MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. SIEMENS HEALTH ATELLICA CI 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	04/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident occurred outside the united states (ous).The ous customer reported an observation of an elevated atellica ci carcinoembryonic antigen (cea) lot 222 patient sample result with that was discordant relative to a lower retest result.The customer is aware of the special reagent mixing requirement in the assay's instructions for use (ifu) but has observed reagent clumping and high cv on the calibrators.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 obtained an elevated patient sample result with atellica ci carcinoembryonic antigen (cea) lot 222 that was discordant relative to a lower retest result.There are no allegations of patient or user intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
Siemens filed mdr 1219913-2025-00102 initial report on 27-may-2025.Siemens completed investigation of an outside the united states (ous) customer report of an elevated atellica ci carcinoembryonic antigen (cea) lot: 222 patient sample result that was discordant relative to a lower retest result.The customer reported imprecision with the cea assay lot: 222 on the atellica ci#: irc006202322 observing variation between runs at the low end of the assay analytical measuring range (amr), which led to the discordance.Siemens confirmed that the customer is performing the required special reagent mixing requirement in the assay's instructions for use (ifu) and inspecting all packs for clumping and particle settling prior to loading onto the analyzer.No related shipment/storage/handling conditions were reported or identified, but faint bands were observed on the onboard reagent readypacks.The customer began use of reagent lot: 222 on 04-apr-2025.Siemens reviewed the atellica ci analyzer data summary extraction file for cea on atellica ci#: irc006202322 with date range of 01-april-2025 to 07-may-2025.Siemens' analysis confirmed there was no calibration related problem.However, imprecision was noted on four different patient samples tested between 16-apr-2025 through 27-apr-2025, tested with different reagent readypacks of lot: 222.There has been no recurrence of imprecision besides these samples.There was no hemolysis, icterus, and lipemia (hil) noted with the samples.Siemens reviewed the individual trace files for the four sample replicates, and they did not show any specific signature that would lead to imprecision or outlier in the data.However, there were indications of electrical interference related to a particular analyzer part.Siemens recommended part replacement, but the customer stated that they began use of a different reagent lot, will be monitoring the system and confirmed no further support was required at this time.Based on the investigation, the cause of the discordant result cannot be confirmed, but appears to be related to electrical interference due to potential part malfunction.A product issue was not identified.The customer is operational, and the reported issue was resolved by routine troubleshooting.In section h6 of this report, the investigation finding and conclusion codes were updated based on the investigation results.

• Brand Name: ATELLICA CI CARCINOEMBRYONIC ANTIGEN (CEA)
• Common Device Name: SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC. SIEMENS HEALTH; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; registration # 1219913; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032
• MDR Report Key: 22085342
• Report Number: 1219913-2025-00102
• Device Sequence Number: 20804633
• Product Code: DHX
• UDI-Device Identifier: 00630414598505
• UDI-Public: (01)00630414598505(10)21203222(17)250717
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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): 06/27/2025

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: 07/17/2025
• Device Model Number: N/A
• Device Catalogue Number: 10995523
• Device Lot Number: 21203222
• 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: 04/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2024
• 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