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

Catalog Number	11776193122
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The alleged samples were requested for investigation.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys ca 19-9 results for 1 patient on a cobas e 602 module.An interference with the elecsys ca 19-9 assay was suspected.On (b)(6) 2025, the patient's result was 793.5 u/ml.On (b)(6) 2025, a new sample was obtained, and the result was 836.6 u/ml.On (b)(6) 2025, a new sample was obtained, and the result was >1000 u/ml.A dilution (1:10) was performed, and the result was 1370 u/ml.On (b)(6) 2025, a new sample was obtained, and the result was >1000 u/ml.A dilution (1:10) was performed, and the result was 1064 u/ml.The results were inconsistent with the patient's clinical diagnosis (not provided).
Additional Manufacturer Narrative
On (b)(6) 2026, the patient's ca 19-9 result was 149.7 u/ml.On (b)(6) 2026, the patient's ca 19-9 result was 22.4 u/ml.The qc and calibration were acceptable.The sample from (b)(6) 2025 was returned for investigation.The investigation result (792 u/ml) was consistent with the customer's result (836.6 u/ml).No interfering substance was detected in the returned sample during the investigation.The investigation did not identify a product problem.

• Brand Name: ELECSYS CA 19-9
• Common Device Name: TEST, CARBOHYDRATE ANTIGEN (CA19-9)
• 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: 24094700
• Report Number: 1823260-2026-00193
• Device Sequence Number: 13347398
• Product Code: NIG
• UDI-Device Identifier: 04015630904297
• UDI-Public: 04015630904297
• 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): 03/04/2026

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: 11776193122
• Device Lot Number: 857263
• 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: 12/25/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 03/04/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LIPID-LOWERING MEDICATION.; OSELTAMIVIR.
• Patient Age: 67 YR
• Patient Sex: Male