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); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys estradiol iii assay results for two patient samples tested on the cobas e 411 analyzer (disk system).Sample 1: initial analysis yielded a result of 815.9 pg/ml.Repeat analysis yielded a result of <5 pg/ml.Sample 2: initial analysis yielded a result of >3000 pg/ml with a data flag.Repeat analysis yielded a result of <5 pg/ml.
Additional Manufacturer Narrative
The elecsys estradiol iii assay reagent lot number is 92181901 (expiration date: 31-dec-2026).The customer modified the analyzer's system date to a past date.The customer reseated a dislodged tube in the analyzer; the field service engineer subsequently replaced the tube.The investigation determined that the dislodged tube 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: 50817046
• Report Number: 1823260-2026-03826
• Device Sequence Number: 10680783
• Product Code: JJE
• UDI-Device Identifier: 04015630937103
• UDI-Public: 04015630937103
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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): 09/18/2026

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: 08/26/2026
• Initial Report FDA Received Date: 09/18/2026
• 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