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	02/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested for troponin t on a cobas 8000 e 801 module.The customer noted they were also receiving sample clot detection errors.The complained sample, collected at 13:41, initially resulted in a troponin t value of 32.6 ng/l.A second sample collected from the patient at 17:52 resulted in a troponin t value of 3 ng/l.A third sample collected from the patient at 23:36 resulted in a troponin t value of < 3 ng/l.The complained sample was repeated on (b)(6) 2026, resulting in a troponin t value of 6.4 ng/l.This value was more in line with the patient's history.
Additional Manufacturer Narrative
The troponin t reagent lot number and expiration date were requested, but not provided.The field service engineer checked the sample probe stream, checked pressure sensor function, and checked the syringe.The probe was observed to be dripping.Connections were checked over and all were good.Probe tubing was found damaged and there was water on surrounding circuit boards.The sample pipettor assembly was replaced.Probe adjustments were performed and the system was primed.An instrument check was performed and passed.No further issues were reported by the customer after these actions.The investigation is ongoing.
Additional Manufacturer Narrative
Quality controls were acceptable prior to the event.The investigation determined the service actions resolved the issue.

• 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: 24455684
• Report Number: 1823260-2026-00711
• Device Sequence Number: 10052316
• 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): 03/30/2026

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: 02/11/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/30/2026
• 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