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

Model Number	e 411
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys estradiol iii assay results for 1 patient sample on a cobas e 411 analyzer (rack system).The initial result was >3000 pg/ml with a data flag.Because the result had a data flag, the sample was repeated with a (1:10) dilution, and the result was 275.4 pg/ml.The sample was repeated without dilution, and the results were 37.32 pg/ml, 22.74 pg/ml, and 21.43 pg/ml.The result of 21.43 pg/ml was believed to be correct.The results of 22.74 pg/ml and 21.43 pg/ml were obtained using a different reagent pack.The questionable results were not reported outside the laboratory.
Additional Manufacturer Narrative
The reagent lot number is 921819.The expiration date was not provided.The qc and calibration were acceptable.The field service representative found that the sipper probe was misaligned.He replaced the mixer paddle and the sipper probe.He performed adjustments and alignments and reinstalled the assembly.He performed checks and tests with acceptable results.The investigation is ongoing.

• Brand Name: cobas e 411 analyzer (rack 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: 50914898
• Report Number: 1823260-2026-03974
• Device Sequence Number: 17485293
• Product Code: JJE
• UDI-Device Identifier: 04015630924721
• UDI-Public: 04015630924721
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K961481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/28/2026
• 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: Female