MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CA 19-9; CARBOHYDRATE ANTIGEN (CA19-9) TEST SYSTEM

Catalog Number	07027028190
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	05/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ca 19-9 reagent expiration date was not provided.The e801 analytical unit serial number was (b)(6).The qc was acceptable.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with elecsys carbohydrate antigen 19-9 (ca 19-9) assay on a cobas e801 analytical unit.Initial result: 51.1 u/ml.The initial result did not match the patient's clinical diagnosis, and the sample was repeated.1st repeat result: 11.8 u/ml.2nd repeat result: 11.6 u/ml.No questionable result was reported outside the laboratory.
Additional Manufacturer Narrative
Section d4 was updated.The calibration signals prior to the event were within the expected range.The assay performance check was last performed on 03-oct-2024 with successful results.According to the provided data, the customer performs the calibration regularly, and the calibration signals prior to the event were within the expected range.A general reagent or analyzer problem can be excluded because the qc prior to the event was within the ranges.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS CA 19-9
• Common Device Name: CARBOHYDRATE ANTIGEN (CA19-9) 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: 22183076
• Report Number: 1823260-2025-01791
• Device Sequence Number: 8690459
• Product Code: NIG
• UDI-Device Identifier: 04015630939640
• UDI-Public: 04015630939640
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050231
• 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): 07/14/2025

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: 03/31/2026
• Device Catalogue Number: 07027028190
• Device Lot Number: 794179
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/14/2025
• 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 Age: 50 YR
• Patient Sex: Female
• Patient Race: Asian