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	09/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys estradiol iii assay results for 2 patient samples on a cobas e 411 analyzer (disk system).Patient 1's initial result was 680.8 pg/ml.The repeat results were 51.72 pg/ml and 61.05 pg/ml.Patient 2's initial result on 09-sep-2026 was 166.7 pg/ml.The repeat result was 52.57 pg/ml.The repeat results were deemed to be correct, as the initial high results did not match clinical expectations.
Additional Manufacturer Narrative
The elecsys estradiol iii assay reagent lot number is 97554301, and the expiration date is 30-jun-2027.Qc was within range at the time of the event on 07-sep-2026.The system was released for sample measurement.The qc level 2 was out of range on 08-sep-2026.Qc results for 09-sep-2026 were not available.A field service engineer (fse) determined that the z-motor of the pipetting/reagent needle was the root cause.The fse disassembled all of the covers, cleaned all surfaces to remove dust, and replaced the z-motor of the pipetting/reagent needle.For verification, calibration runs, and patient sample processing were performed without any issues.The analyzer is working according to specification after the service.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: 50931704
• Report Number: 1823260-2026-04006
• Device Sequence Number: 18564184
• Product Code: JJE
• UDI-Device Identifier: 04015630937103
• UDI-Public: 04015630937103
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/29/2026

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: 09/08/2026
• Initial Report FDA Received Date: 09/29/2026
• 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