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

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	04/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted a siemens customer care center (ccc) and reported elevated atellica im carcinoembryonic antigen (cea) results, which were discordant relative to repeat testing on alternate analyzers.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 evaluating the event.
Event or Problem Description
The customer reports observation of elevated atellica im carcinoembryonic antigen (cea) results when using reagent lot#: 222, which were discordant relative to repeat testing on alternate analyzers.An initial elevated cea result was obtained for a patient sample.This result was reported to the physician.The sample was repeated twice on the original atellica im analyzer, and the repeat results recovered lower but were over the reference range.The same sample was reprocessed again with heterophilic blocking tube (hbt) testing on an alternate atellica im analyzer (s/n: (b)(6) and obtained an elevated result equivalent to the initial erroneous result.The sample was then repeated on an alternate test method (roche analyzer) and obtained a lower result recovered within the reference range, which was considered correct, and all the repeat results were reported to the physician.The sample was manually diluted five times and again tested on an unknown analyzer, and the fifth repeat result recovered lower but was over the reference range.There are no known reports of patient intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
Siemens filed initial mdr 1219913-2025-00109 on 5-jun-2025.Additional information (18-jun-2025): siemens healthcare diagnostics has concluded the investigation of the event.An outside united states (ous) customer reported an observation of elevated atellica im carcinoembryonic antigen (cea) results, which were discordant relative to repeat testing.Siemens evaluated the instrument data and the information provided by the customer.Reagent observations were ruled out based on review of qc, which showed recovery within acceptable ranges and no issues were reported with other patient samples.Based on the limited information provided and the unavailability of sample, further evaluation is not possible, and the cause of the discordant result was unable to be determined.A product problem has not been identified.The customer is operational, and the reported issue was resolved by routine troubleshooting.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: ATELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA)
• 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: 22148200
• Report Number: 1219913-2025-00109
• Device Sequence Number: 20741685
• Product Code: DHX
• UDI-Device Identifier: 00630414598505
• UDI-Public: (01)00630414598505(10)21202222(17)250717
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 07/11/2025

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: 21202222
• 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: 05/12/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2024
• 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 Age: 47 YR
• Patient Sex: Female