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	03/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the e411 analyzer is (b)(6).Rack adapters required for 13 mm.Diameter tubes were not used when the first two samples were tested.The sample tubes used were 13 x 75 mm.On (b)(6) 2026, the field service engineer found dirt and residue on analyzer parts.Patient samples were checked and no fibrin or clots were detected.Samples 1 and 2 were repeated in the same run that included a high concentration sample.The repeat results were all < 0.100 miu/ml.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for four patient samples tested with elecsys hcg+beta on a cobas e411 rack.The first sample initially resulted in an hcg+beta value of 340.3 miu/ml with a data flag.The sample was repeated on (b)(6) 2026, resulting in a value of < 0.100 miu/ml with a data flag.The second sample initially resulted in an hcg+beta value of 4.36 miu/ml on (b)(6) 2026.The sample was repeated, resulting in a value of < 0.1 miu/ml with a data flag.The third sample initially resulted in an hcg+beta value of 5.14 miu/ml with a data flag on 18-(b)(6) 2026.The sample was repeated on (b)(6) 2026, resulting in a value of < 0.100 miu/ml with a data flag.The sample was repeated on (b)(6) 2026, resulting in a value of < 0.100 miu/ml with a data flag.The fourth sample initially resulted in an hcg+beta value of 9.60 miu/ml with a data flag on (b)(6) 2026.The sample was repeated on (b)(6) 2026, resulting in a value of < 0.100 miu/ml with a data flag.The sample was repeated on (b)(6) 2026, resulting in a value of < 0.100 miu/ml with a data flag.
Additional Manufacturer Narrative
Quality controls were acceptable prior to the event.An issue with the analyzer or reagent can be ruled out.A review of alarm trace data showed no relevant alarms.The investigation determined the issue is consistent with insufficient pre-analytic sample handling as required rack adapters were not used for primary tubes.

• 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 46250-0457
• MDR Report Key: 24788858
• Report Number: 1823260-2026-01294
• Device Sequence Number: 21023783
• Product Code: JJE
• UDI-Device Identifier: 04015630924721
• UDI-Public: 04015630924721
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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): 05/07/2026

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
• Device Lot Number: 868696
• 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: 03/12/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 05/07/2026
• 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