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

Model Number	E 411
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with elecsys ft4 iv assay on a cobas e 411 analyzer (rack system).Initial result: 0.039 ng/dl (accompanied by a data flag).Repeat result: 2.36 ng/dl.
Additional Manufacturer Narrative
The elecsys ft4 iv reagent lot number and expiration date were not provided.The sample was visually inspected, and no clot or fibrin was observed.The qc was within range prior to the sample measurement.No relevant alarms occurred.The customer stated that they perform the liquid flow cleaning (lfc) on a weekly basis, but at the time of analysis, the lfc had not been performed for two weeks.The measuring cell needed replacement.The sample probe was not cleaned on a daily basis.The customer observed a strange trace of sticky, brownish substance on the reagent cover that had to be cleaned with a damp cloth using distilled water.The instrument surfaces were not adequately cleaned.The field service engineer found that the bead mixer was bent.He adjusted the bead mixer.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 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: 25001608
• Report Number: 1823260-2026-01622
• Device Sequence Number: 12943940
• Product Code: JJE
• UDI-Device Identifier: 04015630924721
• UDI-Public: 04015630924721
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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,Followup
• Report Date (Section B): 05/22/2026

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): Follow-Up
• Initial Date Received by Manufacturer: 04/03/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 05/22/2026
• 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