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

Model Number	E 411
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number and the expiration date were requested but not provided.The field service engineer (fse) inspected the analyzer and identified the sample/reagent probe as the root cause.He detected slight oxidation or corrosion on the probe contacts, leakage from the probe tip, and incorrect liquid-level detection voltages.He performed a detailed inspection of all these parts and replaced the tubing and seals.He verified the analyzer's performance with qcs.The investigation determined that a component failure (sample/reagent probe) caused the event.The investigation determined that the service actions resolved the issue.
Event or Problem Description
The initial reporter received a questionable vitamin b12 assay result from one patient sample tested on the cobas e 411 analyzer (rack system).The initial result was >2000 pg/ml with a data flag.The repeat result was 80.5 pg/ml.The initial result was not reported outside of the laboratory.The repeat result was deemed correct.

• 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: 24755021
• Report Number: 1823260-2026-01196
• Device Sequence Number: 8743773
• Product Code: JJE
• UDI-Device Identifier: 04015630924721
• UDI-Public: 04015630924721
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: 03/10/2026
• 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