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

Catalog Number	07027079190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e801 analytical unit serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 4 patients' samples tested with elecsys cea assay on a cobas e801 analytical unit.Sample 1: initial result: <0.3 ng/ml (accompanied by a data flag).Repeat result: 855 ng/ml.Sample 2: initial result: <0.3 ng/ml (accompanied by a data flag).Repeat result: 7.69 ng/ml.Sample 3: initial result: <0.3 ng/ml (accompanied by a data flag).Repeat result: 2.87 ng/ml.Sample 4: initial result: <0.3 ng/ml (accompanied by a data flag).Repeat result: 1.89 ng/ml.The initial results were lower than the technical test limit, prompting the repeat of the samples.The repeat results were deemed to be correct.
Additional Manufacturer Narrative
A general reagent or analyzer problem can be excluded because the qc after the event was within ranges.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 21996643
• Report Number: 1823260-2025-01458
• Device Sequence Number: 17262805
• Product Code: DHX
• UDI-Device Identifier: 04015630939664
• UDI-Public: 04015630939664
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 06/16/2025

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: 10/31/2025
• Device Catalogue Number: 07027079190
• Device Lot Number: 80117601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 06/16/2025
• 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