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	01/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The elecsys troponin t hs stat reagent lot number is 86958601, with an expiration date of 31-aug-2026.The hcg+beta elecsys reagent lot number is 83810501, with an expiration date of 31-mar-2026.The field service engineer performed preventive maintenance and replaced the syringe seals, pinch tubing, sample/sipper tubing, syringe block, and o-rings.He also cleaned and lubricated the sampler, sipper, gripper, and waste agitator.He replaced the measuring cell, primed the system, and performed multiple cell preparations.He cleared the calibration database and cell counters and performed successful qc runs.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys troponin t hs stat and hcg+beta elecsys assay results from two patient samples tested on the cobas e 411 analyzer (disk system).Patient sample 1: elecsys troponin t hs stat, on (b)(6) 2026: the initial result was 18 ng/l.On (b)(6) 2026.The initial result of a repeat patient sample was 7 pg/ml with a delta flag.The repeat result of the repeat patient sample after recentrifugation was also 7 pg/ml.The repeat result after the initial patient sample was recentrifuged and aliquoted was 7.42 pg/ml or 7 ng/l.Patient sample 2: hcg+beta elecsys, on (b)(6) 2026: the initial result of the initial patient sample was 0.655 iu/l.The result of a new patient sample triggered a delta flag.The repeat result of the initial patient sample was >1000 iu/l with a data flag.The repeat result of the diluted patient sample was 92835 iu/l with a data flag.The repeat results were deemed correct.
Additional Manufacturer Narrative
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
• MDR Report Key: 24550067
• Report Number: 1823260-2026-00821
• Device Sequence Number: 14852299
• Product Code: JJE
• UDI-Device Identifier: 04015630937103
• UDI-Public: 04015630937103
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 04/08/2026

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: 02/12/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/08/2026
• 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