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	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys ca 19-9 results for 1 patient sample on a cobas 8000 e 801 module.The initial result is 69.1 u/ml.The repeated result is 3.99 u/ml (reported as 4.0 u/ml).This result was consistent with the patient's clinical history.
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).Two of the qc levels (1 and 3) were acceptable, but one of the levels (level 2) was not tested.The investigation is ongoing.
Additional Manufacturer Narrative
The calibration was acceptable.A general product problem was excluded.A sample clot alarm was detected twice.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: 23865979
• Report Number: 1823260-2025-05280
• Device Sequence Number: 11871707
• Product Code: NIG
• UDI-Device Identifier: 04015630939640
• UDI-Public: 04015630939640
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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): 03/23/2026

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 Catalogue Number: 07027028190
• Device Lot Number: 849083
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 03/23/2026
• 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 Age: 74 YR
• Patient Sex: Male