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

Catalog Number	07682913001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number and expiration date were not provided.The field service engineer replaced the pinch valve tube and replaced and adjusted the sipper probe.Preventive replacement and adjustment of the reagent probe were performed.The shipper line and washing tank were cleaned.Qc was performed and was acceptable.The investigation was unable to determine a specific root cause.However, the issue appeared to be resolved after the service actions.
Event or Problem Description
There was an allegation of questionable high elecsys estradiol iii results for patient samples and qc material from the cobas e 801 module.One example was an initial result of 5.0 or less pg/ml and repeat results of 48.9 pg/ ml and 5.0 or less.The result of 5.0 or less was reported outside of the laboratory.

• 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: 23980364
• Report Number: 1823260-2026-00079
• Device Sequence Number: 10717050
• Product Code: JJE
• UDI-Device Identifier: 04015630946198
• UDI-Public: 04015630946198
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 01/06/2026

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/25/2025
• Initial Report FDA Received Date: 01/06/2026
• 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