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

Catalog Number	11776193122
Medical Device Problem Codes	High Test Results (2457); Insufficient Device Problem Information (3190); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys ca 19-9 results from the cobas 6000 e601 module.On (b)(6) 2025 the initial result was 42.92 u/ml, and the repeat result was 17.84 u/ml.The questionable result was not released outside of the lab and the repeat result was deemed to be correct.On (b)(6) 2025 the initial result was 162.4 u/ml, and the repeat results were 17.05 u/ml, 11.73 u/ml, and 12.4 u/ml.On (b)(6) 2025 the initial result was 28.45 u/ml, and the repeat results with a different reagent pack were 6.45 u/ml, 6.27 u/ml, and 6.27 u/ml.
Additional Manufacturer Narrative
The cobas 6000 e601 module serial number is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Due to the limited information available about the issue, a direct root cause could not be determined.

• Brand Name: ELECSYS CA 19-9 IMMUNOASSAY
• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21526381
• Report Number: 1823260-2025-00633
• Device Sequence Number: 8378687
• 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): 04/10/2025

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: 11776193122
• Device Lot Number: 782391
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 04/10/2025
• 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