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	03/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys vitamin b12 ii results for 3 patient samples on a cobas e 411 analyzer (rack system).On (b)(6) 2026, sample 1 had an initial result of <36.90 pmol/l.The repeat result was 389.50 pmol/l.On (b)(6) 2026, sample 2 had an initial result of<36.90 pmol/l.The repeat result was 206.8 pmol/l.Another sample tube collected at the same time was tested, and the result was 238 pmol/l.The two repeat results were deemed correct.On (b)(6) 2026, sample 3 had an initial result of <36.90 pmol/l.The repeat result was 220.44 pmol/l.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
The reagent lot number is 839242.The expiration date was not provided.The calibration and qc recovery data provided was within specification.The alarm trace did not contain a conspicuous event.The investigation is ongoing.
Additional Manufacturer Narrative
The field service engineer (fse) found issues with the pinch tubes and liquid level detection.The fse replaced the liquid level detection assembly and the pinch tubes and performed qc successfully.The investigation determined that the issues found by the fse were the root cause of the event.

• 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: 24876379
• Report Number: 1823260-2026-01415
• Device Sequence Number: 10019792
• Product Code: JJE
• UDI-Device Identifier: 04015630924721
• UDI-Public: 04015630924721
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 06/15/2026

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: 03/18/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 06/15/2026
• 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 Age: 63 YR
• Patient Sex: Male