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

Catalog Number	11776193122
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 411 analyzer (disk system) serial number is (b)(6) the samples have been requested for investigation.The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable elecsys ca 19-9 result from the cobas e 411 analyzer (disk system) for one patient.The initial result was 1000 u/ml, accompanied by a data flag.The second result with a dilution of 1:10 was 172 u/ml.The third result was 331.4 u/ml.The result on another e411 was 1000 u/ml, accompanied by a data flag.A new sample was collected on the same day, and the initial result was 29.71 u/ml.The results from the other e411 were 27.22 u/ml and 32.65 u/ml, which were deemed to be correct.On (b)(6) 2025, the sample was sent to another lab.The result on an e 411 was 219.7 u/ml.
Additional Manufacturer Narrative
An additional result was provided for the patient from (b)(6) 2025, of 121.6 u/ml.Qc was within range on the date of the event.Calibration signals were slightly lower but acceptable.The sample was requested but is not available for investigation; therefore, a thorough investigation could not be completed.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: 24038449
• Report Number: 1823260-2026-00142
• Device Sequence Number: 13380195
• Product Code: NIG
• UDI-Device Identifier: 04015630904297
• UDI-Public: 04015630904297
• Combination Product (Y/N): N
• Initial Reporter Country: MO
• 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): 02/03/2026

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: 12/22/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/03/2026
• 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 Sex: Unknown