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

Model Number	E 411
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with the elecsys testosterone ii assay on a cobas e 411 analyzer.No questionable results were reported outside of the laboratory.The repeat value was deemed correct.The sample initially resulted in a testosterone value of 8.97 ng/ml.The sample was repeated on (b)(6) 2026, resulting in a value of 4.29 ng/ml.
Additional Manufacturer Narrative
The testosterone reagent lot number was 851750.The reagent expiration date was requested, but not provided.Calibration and controls were acceptable.It was observed that the mixer was causing foam formation.The field service engineer checked the analyzer, including checking the mixer, probe adjustments, probe tubing, liquid level detection voltage, grounding, and water conductivity.The uninterruptible power supply unit had a plug that was reversed, which caused the potential difference between neutral and ground to be > 10 volts.The plug was corrected.Grounding and liquid level detection voltage were re-checked.Performance testing was run and within specifications.The investigation determined the issue is consistent with insufficient maintenance.It was determined that adjustments to the mixer and sample probe liquid level detection were needed.The issue was resolved after performance of the service actions.

• 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: 25027217
• Report Number: 1823260-2026-01685
• Device Sequence Number: 10126440
• Product Code: JJE
• UDI-Device Identifier: 04015630924721
• UDI-Public: 04015630924721
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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): 04/29/2026

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: 04/19/2026
• Initial Report FDA Received Date: 04/29/2026
• 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