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

Model Number	E 411
Medical Device Problem Codes	Infusion or Flow Problem (2964); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot numbers are: elecsys ft4 iv - 884942 elecsys tsh v2 - 906453 elecsys vitamin b12 ii immunoassay - 839234 elecsys ferritin - 878141 the expiration dates were not provided.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys ft4 iv, elecsys tsh v2, elecsys vitamin b12 ii immunoassay, and elecsys ferritin assay results for four patient samples tested on the cobas e 411 analyzer (disk system).Elecsys ft4 iv patient sample 1 the initial result is <0.101 ng/dl.The repeat result is 1.09 ng/dl.Elecsys tsh v2 patient sample 2 the initial result is 0.02 uiu/ml.The repeat result is 1.85 uiu/ml.Elecsys vitamin b12 ii immunoassay patient sample 3 the initial result is <150 pg/ml.The repeat result is 710.5 pg/ml.Elecsys ferritin patient sample 4 the initial result is 1.8 ng/ml.The repeat result is 70.70 ng/ml.The doctor questioned the low tsh result, and multiple assays had low results, prompting the rerun.The repeat results were deemed correct.
Additional Manufacturer Narrative
The field service engineer (fse) inspected the module and found the sample and reagent probe tubing off the tensioning pulley system, resulting in sampling errors.He replaced this part, cleaned and lubricated the sample and reagent probe linear bearings, and performed preventive maintenance.He verified the module's performance with artificial media, mechanical, instrument, and precision checks.The investigation determined that a component failure caused the event.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: 24816652
• Report Number: 1823260-2026-01337
• Device Sequence Number: 17678629
• Product Code: JJE
• UDI-Device Identifier: 04015630937103
• UDI-Public: 04015630937103
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 06/23/2026

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: 03/18/2026
• Supplement Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 06/23/2026
• 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 Age: 82 YR
• Patient Sex: Female