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

Model Number	E 411
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys cortisol ii (cortisol ii) results for two patient samples tested on the cobas e 411 analyzer (disk system).Patient sample 1: the initial result was >63 g/dl.The repeat result was 21.0 g/dl.Patient sample 1: the initial result was >63 g/dl.The repeat result was 12.0 g/dl.The initial results were deemed abnormally high.The repeat results were deemed correct, as they were consistent with the patients' previous results.
Additional Manufacturer Narrative
The reagent lot number and the expiration date were requested but not provided.The field service engineer inspected the analyzer and found the sample/reagent (s/r) probe tubing derailed from the pulley, causing a possible malfunction in the liquid level sensor.He replaced the s/r probe tubing, cleaned the analyzer, checked the s/r probe positions and adjustments, checked the voltages, adjusted the liquid level sensor, and verified the voltage monitor.He verified the analyzer's performance with operational and functional checks and qcs.The investigation determined that a component failure (s/r probe tubing) caused the event.The investigation determined that the service actions resolved the issue.

• Brand Name: COBAS E 411 ANALYZER (DISK 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: 24826427
• Report Number: 1823260-2026-01353
• Device Sequence Number: 15745390
• Product Code: JJE
• UDI-Device Identifier: 04015630937103
• UDI-Public: 04015630937103
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/09/2026

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: 04775279001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 04/09/2026
• 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