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

Catalog Number	07027028190
Medical Device Problem Codes	Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable elecsys ca 19-9 assay result for a patient sample tested on a cobas e 801 analytical unit.The initial result was <10000 u/ml.The repeat results were <10000 and 46.3 u/ml with dilution.
Additional Manufacturer Narrative
The serial number of the analyzer was (b)(6).The field service engineer (fse) replaced the gear pump head and the measuring cells since the lifetime threshold was reached, and one measuring cell had more than 100000 tests.The investigation is ongoing.
Additional Manufacturer Narrative
Data analysis revealed that the calibration and qc were within the acceptable range.Therefore, a general reagent problem could be excluded as the qc within the range on the date of event.It was reported that a field service engineer was dispatched and changed the gear pump head and the measuring cells since the lifetime threshold was reached, and one measuring cell had more than 100000 tests.No further issues were reported.As no further information was provided, the root cause could not be determined.
Additional Manufacturer Narrative
H6 coding (medical device problem code) has been updated.

• Brand Name: ELECSYS CA 19-9
• Common Device Name: CARBOHYDRATE ANTIGEN (CA19-9) TEST SYSTEM
• 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: 23594546
• Report Number: 1823260-2025-04706
• Device Sequence Number: 13171947
• Product Code: NIG
• UDI-Device Identifier: 04015630939640
• UDI-Public: 04015630939640
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 03/05/2026

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: 07027028190
• Device Lot Number: ASKU
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: 12/23/2025; 02/13/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 01/12/2026; 03/05/2026
• 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