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

Catalog Number	11776193122
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	05/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable elecsys ca 19-9 result from the cobas e 411 analyzer (disk system).The initial result on (b)(6) 2025 was <0.6 u/ml, and the repeat result was 49.54 u/ml.
Additional Manufacturer Narrative
The cobas e 411 analyzer (disk system) serial number is (b)(6).The last calibrations provided was performed on 01-aug-2024, which is not the recommended interval.Qc data was not provided.The alarm trace was not provided for the date of the event.The investigation is ongoing.
Additional Manufacturer Narrative
A field service engineer (fse) performed an artificial media test (am test), and it failed for dilution 1:20 precision.Due to this issue, the sample probe was replaced, and the test was repeated.The second am test passed completely.The alarm trace that was provided was not from the range of time of the event.However, there were several occurrences of sample quality-related alarms, such as insufficient sample or pipette clog, which is consistent with pre-analytical issues.The investigation was unable to determine a direct root cause.

• 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: 22116019
• Report Number: 1823260-2025-01672
• Device Sequence Number: 20626934
• Product Code: NIG
• UDI-Device Identifier: 04015630904297
• UDI-Public: 04015630904297
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 07/01/2025

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: 05/07/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 07/01/2025
• 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