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	04/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 1 serial number was (b)(6).The cobas 2 serial number was (b)(6).The estradiol iii reagent lot number was 921819 with an expiration date of 31-dec-2026.The customer mentioned that the calibration and qc were acceptable.The pre-analytical data were within specifications, and no sample issue was detected.No reagent issue was found.For cobas 2: sporadic liquid level detection (lld) alarms occurred repeatedly.For cobas 1: the field service engineer (fse) replaced the needle and the lld board and adjusted the voltage.Estradiol iii tests and an assay performance check were performed with successful results.The fse confirmed that the analyzer was performing within specifications.The service actions performed by the fse resolved the issue.The cause of the event was due to an issue with the lld board (component failure).
Event or Problem Description
We received an allegation about discrepant results for 4 patients' samples tested with elecsys estradiol iii assay on a cobas e 411 analyzer (disk system).Sample 1: initial result: 605.9 pg/ml (tested on cobas 2).Repeat result: 273 pg/ml (tested on cobas 1).Sample 2 was tested on (b)(6) 2026: initial result: 821.3 pg/ml (tested on cobas 1).Repeat result: 124.3 pg/ml (tested on cobas 2).Sample 3 was tested on (b)(6) 2026: initial result: 1551.2 pg/ml (tested on cobas 1).Repeat result: 55.46 pg/ml (tested on cobas 2).The physician questioned the initial results as they did not match the patients' clinical pictures, prompting the repeat of the samples.Sample 4 was tested on (b)(6) 2026: the sample was initially tested and repeated on a different analyzer: initial result: <5.00 pg/ml.Repeat results: 1198 pg/ml, 857 pg/ml, 197.3 pg/ml, >3000 pg/ml, 504.3 pg/ml, and <5.00 pg/ml.Last repeat result: 999.1 pg/ml (tested on cobas 1).

• Brand Name: COBAS E 411 ANALYZER (DISK 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: 25287144
• Report Number: 1823260-2026-02068
• Device Sequence Number: 13153518
• 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): Unknown
• 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): 05/26/2026

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 05/26/2026
• 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