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

Model Number	e 411
Medical Device Problem Codes	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	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys hcg stat and elecsys troponin t hs stat assay results for multiple patient samples tested on the cobas e 411 analyzer (disk system).The following patient samples with discrepant results were provided: patient sample 1 hcg initial analysis of the patient sample yielded <1 miu/ml.Repeat analysis yielded 542 and 534 miu/ml.Patient sample 2 troponin t hs initial analysis of the patient sample yielded 22 ng/l.Repeat analysis yielded 9 ng/l.Patient sample 3 troponin t hs initial analysis of the patient sample yielded 25 ng/l.Repeat analysis yielded 6 ng/l.
Additional Manufacturer Narrative
The reagent lot numbers are: elecsys hcg stat - 869013 elecsys troponin t hs stat - 924462 the expiration dates were not provided.The field service engineer inspected the module and identified that the paddle mixer screw caused the event.He repaired and adjusted parts, and verified that the analyzer was performing according to specifications.The investigation determined that the identified component failure had caused the event.The investigation determined that the service actions 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 -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: 50899601
• Report Number: 1823260-2026-03954
• Device Sequence Number: 14952656
• Product Code: JJE
• UDI-Device Identifier: 04015630937103
• UDI-Public: 04015630937103
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K961481
• Number of Events Summarized: 1
• Summary Report (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): 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: 04775279001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/03/2026
• 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