MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 411 ANALYZER (DISK 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	03/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The progesterone reagent lot number is 86105100 and the expiration date is 30-apr-2026.The hcg reagent lot number is 86901300 and the expiration date is 31-aug-2026.The field service engineer (fse) performed sample, reagent, and sipper probe primes, modular chemistry conditioning, system volume checks, mechanical checks, blank cell calibration, and precision testing.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys progesterone iii and elecsys hcg stat results for 2 patient samples on a cobas e 411 analyzer (disk system).The doctor questioned the initial results which prompted the customer to repeat the patient samples.On (b)(6) 2026, sample 1 had an initial hcg result of <1.0 miu/ml with flag.On (b)(6) 2026, the sample was repeated and the result was >200 miu/ml.On (b)(6) 2026, sample 2 had an initial progesterone result of >60 ng/ml.The sample was repeated and the result was 0.287 ng/ml.The repeat results were deemed correct.
Additional Manufacturer Narrative
The field service engineer (fse) performed preventive maintenance on the analyzer.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.

• 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: 24717986
• Report Number: 1823260-2026-01147
• Device Sequence Number: 5726617
• Product Code: JJE
• UDI-Device Identifier: 04015630937103
• UDI-Public: 04015630937103
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

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): Follow-Up
• Initial Date Received by Manufacturer: 03/06/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/20/2026
• 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