MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 E 801 MODULE; IMMUNOCHEMISTRY ANALYZER

Catalog Number	07682913001
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer (fse) determined that there were defective tubes and replaced them and the prewash valve bank assembly.The fse ran an instrument check and qcs, which were within specifications.There were no further issues reported.The investigation determined that the service action resolved the issue.
Event or Problem Description
There was an allegation of a questionable elecsys troponin t hs result from the cobas 8000 e 801 module for one patient.The initial result was 68.0 ng/l, and the repeat result was 3.0 ng/l.
Additional Manufacturer Narrative
The elecsys troponin t hs reagent lot number is 847376, and the expiration date was not provided.The customer reported persistent abnormal signals and fliers across channels.The investigation is ongoing.

• Brand Name: COBAS 8000 E 801 MODULE
• 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: 24116951
• Report Number: 1823260-2026-00209
• Device Sequence Number: 5941655
• Product Code: JJE
• UDI-Device Identifier: 04015630946198
• UDI-Public: 04015630946198
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K060373
• 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): 02/19/2026

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 Catalogue Number: 07682913001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 02/19/2026
• 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