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

Catalog Number	07682913001
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent information was not provided.The customer performed analyzer maintenance (liquid flow path cleaning) on both modules and successfully repeated the qc.The investigation determined that the customer's actions resolved the issue.The investigation did not identify a product problem.The root cause of the event could not be determined.
Event or Problem Description
There was an allegation of questionable elecsys tsh, elecsys t4, elecsys ft3 iii, and elecsys ft4 iv results for 2 patient samples on two cobas e 801 modules.For sample 1, the initial tsh result was 0.014 uiu/ml and the initial t4 result was 0.5 ug/dl.The repeat tsh result was 0.833 uiu/ml and the repeat t4 result was 11.4 ug/dl.For sample 2, the initial tsh result was 0.018 uiu/ml, the initial ft3 result was 1.07 pg/ml, the initial ft4 result was 0.04 ng/dl.The repeat tsh result was 3.230 uiu/ml, the repeat ft3 result was 3.49 pg/ml, and the repeat ft4 result was 1.22 ng/dl.Clarification on which module produced which results was not provided.

• 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: 24058685
• Report Number: 1823260-2026-00169
• Device Sequence Number: 10023644
• 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): N
• 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): 01/13/2026

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: 12/16/2025
• Initial Report FDA Received Date: 01/13/2026
• 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