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

Catalog Number	07682913001
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The troponin t hs reagent expiration date was not provided.The cobas e 801 module serial number was (b)(6).The qc was acceptable.The investigation is ongoing.
Event or Problem Description
We received an allegation about disctrepant results for 2 patients' samples tested with elecsys troponin t hs assay on a cobas e 801 module.Patient 1: the initial result was 230 ng/l.The sample was repeated twice on 2 different cobas analyzers, and the repeat results were both < 5 ng/l.Patient 2 was tested on (b)(6) 2025: the initial result was 19.200 ng/l.The sample was repeated twice, and the repeat results were both 3 ng/l.
Additional Manufacturer Narrative
Medwatch fields d1, d2a, d2b, d4, g1 and g4 were updated.The analysis of the provided data showed repeated sample quality-related alarms.The analysis of the sample foam detection (sfd) pictures for the tube showed vibration.Dust was observed on the active gripper, causing contamination on the instrument surface.The field service engineer adjusted and cleaned the washing and the pipettor parts and changed the measuring cells.An instrument check and qc were performed, and they were within specifications.The instrument was performing within specifications.The investigation did not identify a product problem.The cause of the event was consistent with a preanalytic issue (a contamination issue with dusty instrument parts) at the customer site and a maintenance issue.Preanalytics are within the customer's responsibility.

• 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 46250-0457
• MDR Report Key: 24019632
• Report Number: 1823260-2026-00115
• Device Sequence Number: 9136364
• Product Code: JJE
• UDI-Device Identifier: 04015630946198
• UDI-Public: 04015630946198
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 02/06/2026

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
• Device Lot Number: 82723200
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/06/2026
• 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