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

Catalog Number	11776193122
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys ca 19-9 results from one patient sample tested on the cobas e 602 module and cobas e 801 analyzer on (b)(6) 2025: the initial result from the e 602 module is 120 u/ml.The repeat result from the e 602 module with the patient sample at 1:5 dilution was 126.3 u/ml.The repeat result from the e 602 module with the patient sample at 1:10 dilution was 127.8 u/ml.The repeat result from the e 801 analyzer was 75.1 u/ml.The reporter suspected an interferent in the patient sample and performed a polyethylene glycol (peg) treatment test.On (b)(6) 2025: the result of the peg test from the e 602 module was 1.40 u/ml, with a recovery rate of 40%.The reporter stated that this result confirmed an interferent in the patient sample.The result of the parallel test from the module was 121.0 u/ml.The repeat result from a competitor analyzer was 5.19 u/ml.
Additional Manufacturer Narrative
The cobas e 602 module serial number is (b)(6).The cobas e 801 serial number was not provided.The patient sample is insufficient for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation included a review of the calibration report, qc data, and alarm trace: the last calibration was on (b)(6) 2025.The qc results were within the specified ranges.The alarm trace did not indicate any issues.A general reagent-related issue can be excluded.Based on the polyethylene glycol (peg) treatment test performed by the customer, the investigation determined that the event was consistent with an interferent in the patient sample.The investigation did not identify a product problem.

• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22574511
• Report Number: 1823260-2025-02238
• Device Sequence Number: 21200771
• 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): 09/17/2025

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: 78239105
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 09/17/2025
• 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