MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 411 ANALYZER (RACK SYSTEM); IMMUNOCHEMISTRY ANALYZER

Model Number	E 411
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with elecsys tsh assay and elecsys ft4 g4 assay on a cobas e 411 analyzer (rack system).Tsh: initial result: "no value" was generated and (accompanied by a "
Additional Manufacturer Narrative
The tsh reagent lot number was 891754.The ft4 reagent lot number was 883869.The tsh and the ft4 reagents' expiration dates were not provided.The field service engineer (fse) found an issue with the sample probe tubing.He replaced the pinch valve tubings, the sample probe tubings, and primed the sample/reagent probe.He also primed the sipper, adjusted the sample probe liquid level detection voltage, and performed maintenance on the instrument.Qc was performed, and it was within specifications.The fse verified that the instrument was performing within specifications.No further issues were reported after the service visit.The cause of the event was due to a component failure (an issue with the sample probe tubing).

• Brand Name: COBAS E 411 ANALYZER (RACK SYSTEM)
• Common Device Name: IMMUNOCHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 24753443
• Report Number: 1823260-2026-01200
• Device Sequence Number: 10101599
• Product Code: JJE
• UDI-Device Identifier: 04015630924721
• UDI-Public: 04015630924721
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K961481
• 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
• Report Date (Section B): 04/01/2026

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 Model Number: E 411
• Device Catalogue Number: 04775201001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 04/01/2026
• 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