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

Model Number	E 411
Medical Device Problem Codes	Suction Problem (2170); High Test Results (2457); Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable elecsys estradiol iii assay result from the cobas e 411 analyzer (disk system) for 1 patient.The initial result on (b)(6) 2026 was 808.8 pg/ml.The patient returned for repeat testing on (b)(6) 2026, and the new result was significantly lower; the exact result was not available.The initial sample was retested because of the difference in results.The repeat result on (b)(6) 2026 was 23.77 pg/ml.During an on-site investigation, the sample was repeated again, and the result was 30.47 pg/ml.
Additional Manufacturer Narrative
The elecsys estradiol iii assay reagent lot number is 921819, and the expiration date is 31-dec-2026.A field service engineer (fse) executed necessary service maintenance, and the analyzer is now working according to specification.The investigation determined that the service action 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: 25305387
• Report Number: 1823260-2026-02097
• Device Sequence Number: 9579861
• Product Code: JJE
• UDI-Device Identifier: 04015630937103
• UDI-Public: 04015630937103
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K961481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 05/27/2026

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: 05/08/2026
• Initial Report FDA Received Date: 05/27/2026
• 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