MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 411 ANALYZER (DISK SYSTEM); IMMUNOCHEMISTRY ANALYZER

Model Number	E 411
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	Spontaneous Abortion (4514)
Date of Event	02/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The serial numbers of the analyzers are (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys hcg+beta assay results for a patient sample tested on two cobas e 411 analyzers (disk system).On (b)(6) 2026, the initial result was 0.363 iu/l using cobas e 411 sn: (b)(6).The same sample was repeated, and the result was 0.100 iu/l, accompanied by a data flag.The test was repeated as the patient reported that she had already tested positive with a conventional urine test.On (b)(6) 2026, a new sample was obtained and tested on the second cobas e 411 sn: (b)(6) and the result was 1523 iu/l.The original sample from (b)(6) 2026 was repeated on the second cobas e 411 sn: (b)(6) and the result was 747.9 iu/l.Refer to the medwatch with a1 patient identifier (b)(6) for an additional sample involved in the event.
Additional Manufacturer Narrative
The field service engineer (fse) found dirt in the sample/reagent wash station and a defective sipper syringe sensor.The fse replaced several parts, including the sipper syringe sensor, pcb assembly, tube joint, and the measuring cell.Subsequent system checks were successful, confirming proper function of the instrument.Following the fse intervention, no further issues were reported.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 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 46250-0457
• MDR Report Key: 24754819
• Report Number: 1823260-2026-01187
• Device Sequence Number: 8707638
• 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,Followup
• Report Date (Section B): 05/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: E 411
• Device Catalogue Number: 04775279001
• Device Lot Number: 86869601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/09/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 05/01/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female