MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 411 ANALYZER (RACK 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	04/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with elecsys hbsag ii assay and 1 patient sample tested with elecsys anti-hbs assay on a cobas e 411 analyzer (rack system).Sample 1 was tested for hbsag ii: initial result: 1.67 (reactive).On (b)(6) 2026: repeat result: 0.641 (non-reactive).Sample 2 was tested for anti-hbs: initial result: <2.00 iu/l (non-reactive).The physician questioned the initial result, and the sample was repeated.On (b)(6) 2026: repeat result: >1000 iu/l (reactive).
Additional Manufacturer Narrative
The hbsag ii reagent lot number and expiration date were not provided.The anti-hbs reagent lot number was 824064.The expiration date was not provided.The field service engineer (fse) replaced the sipper probe.He replaced and adjusted the sample probe, seal pieces, and the pinch tubings.The fse then rechecked all adjustments and performed an instrument performance test and qc with successful results.The investigation is ongoing.
Additional Manufacturer Narrative
The field service engineer (fse) identified an issue with the sipper nozzle and replaced it.The analyzer was performing within specifications.The service actions performed by the fse resolved the issue in a trained service process.The cause of the event was due to an issue with the sipper nozzle (component failure).

• Brand Name: COBAS E 411 ANALYZER (RACK 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: 25222863
• Report Number: 1823260-2026-01978
• Device Sequence Number: 21325331
• Product Code: JJE
• UDI-Device Identifier: 04015630924721
• UDI-Public: 04015630924721
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2026

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: 04775201001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 06/18/2026
• 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