MAUDE Adverse Event Report: Roche Diagnostics cobas e 411 analyzer (rack system); IMMUNOCHEMISTRY ANALYZER

Model Number	e 411
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable results for multiple assays from the cobas e411 rack analyzer.The samples were repeated on a cobas e 402 analyzer.For the anti-hav igm assay, the elecsys hbsag ii assay, and the elecsys hiv combi pt assay, the results were allegedly false positives.No specific data was provided.The questionable results were not reported outside of the laboratory.
Additional Manufacturer Narrative
The anti-hav igm reagent lot number was 914965.The hbsag assay reagent lot number was 908905.The hiv combi pt reagent lot number was 922989.The expiration dates were not provided.A local biomedical technician inspected the machine and determined that the measuring cell needed to be replaced, and a new blank cell and a cell check were required.The investigation is ongoing.

• Brand Name: cobas e 411 analyzer (rack system)
• Common Device Name: IMMUNOCHEMISTRY ANALYZER
• Manufacturer (Section D): Roche Diagnostics; 9115 hague road; indianapolis IN 46250 -045
• 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: 50900103
• Report Number: 1823260-2026-03963
• Device Sequence Number: 5903750
• Product Code: JJE
• UDI-Device Identifier: 04015630924721
• UDI-Public: 04015630924721
• Combination Product (Y/N): N
• Initial Reporter Country: BH
• PMA/510(K) Number: K961481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• 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): 09/25/2026

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
• Initial Date Received by Manufacturer: 09/05/2026
• Initial Report FDA Received Date: 09/25/2026
• 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