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

Catalog Number	07682913001
Medical Device Problem Codes	Incorrect Measurement (1383); 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	12/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer stated that the qcs were within the specified ranges.The field service engineer inspected the module and determined that the sample probe tips stacked in an overfilled waste chute caused the event.He cleaned the waste liners and waste chutes and verified the module's performance with successful mechanical and precision checks.Product labeling states, "changing solid waste boxes on the e 801 module - when assaytips and assaycups have been consumed and disposed of, you change the solid waste boxes.A solid waste box is also called wasteliner.If the green button for one or both solid waste boxes is flashing, you change the full solid waste boxes for new empty ones.When to change the solid waste boxes is indicated on the reagent overview dialog box or by an instrument alarm." the investigation determined that incomplete customer maintenance caused the event.The investigation determined that the customer maintenance completion resolved the issue.The investigation did not identify a product problem.
Event or Problem Description
The initial reporter received a questionable elecsys vitamin b12 immunoassay result from one patient sample tested on the cobas 8000 e 801 module.The initial result from the module was <150 pg/ml.The repeat result from another module was 906 pg/ml the qc after the patient sample run was out of range, prompting the rerun.The repeat result was deemed correct.
Additional Manufacturer Narrative
The reagent lot number is 87003600.The expiration date was not provided.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: 24077867
• Report Number: 1823260-2026-00179
• Device Sequence Number: 5976369
• Product Code: JJE
• UDI-Device Identifier: 04015630946198
• UDI-Public: 04015630946198
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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: 12/26/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 03/19/2026
• 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