MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CEA; CARCINOEMBRYONIC ANTIGEN TEST SYSTEM

Catalog Number	07027079190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the e 801 analyzer is (b)(6).Calibration signals were lower than expected.Quality controls were within range; therefore, a reagent or analyzer issue can be ruled out.No relevant alarms were observed on the day of the event.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys cea on a cobas e 801 analytical unit.The sample initially resulted in a cea value of 135 ng/ml.New samples collected from the patient were tested for cea at different laboratories on both roche and competitor systems and the results were within expected reference ranges.Specific results could not be provided.The complained sample was repeated on (b)(6) 2025, resulting in a cea value of 1.42 ng/ml.The repeat value was deemed correct by the physician.
Additional Manufacturer Narrative
The investigation determined the issue is consistent with insufficient pre-analytic sample handling.

• Brand Name: ELECSYS CEA
• Common Device Name: CARCINOEMBRYONIC ANTIGEN TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23860433
• Report Number: 1823260-2025-05258
• Device Sequence Number: 4771862
• Product Code: DHX
• UDI-Device Identifier: 04015630939664
• UDI-Public: 04015630939664
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K980887
• 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): 01/21/2026

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: 06/30/2026
• Device Catalogue Number: 07027079190
• Device Lot Number: 85067001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 12/21/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown