MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 402 ANALYTICAL UNIT; CLINICAL CHEMISTRY ANALYZER

Catalog Number	09793020001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The t-uptake reagent lot number was 857107, the t4 reagent lot number was 836916, and the tsh reagent lot number was 849819.The reagent expiration dates were requested, but not provided.The field service engineer found that the pre-wash discharge nozzle was leaking at the tube fitting.The nozzle was tightened to the tubing.Precision studies were successful.Calibration and controls were acceptable.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested on a cobas e 402 analytical unit.Results for the following assays were affected: elecsys t4.Elecsys t-uptake, elecsys tsh.The sample was repeated due to data flags on the initial values for t-uptake and t4.No questionable results were reported outside of the laboratory.The sample initially resulted in the following values: t-uptake = < 57.0 tbi with a data flag t4 = > 24.9 ug/dl with a data flag tsh = 0.316 uiu/ml.The sample was repeated on an unknown device, resulting in the following values: t-uptake = 25 tbi with a data flag t4 = 7.5 ug/dl with a data flag tsh = 1.530 uiu/ml.The repeat values were deemed correct.
Additional Manufacturer Narrative
Calibration data was acceptable.The investigation determined the service actions resolved the issue.

• Brand Name: COBAS E 402 ANALYTICAL UNIT
• Common Device Name: CLINICAL CHEMISTRY 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: 23488032
• Report Number: 1823260-2025-04534
• Device Sequence Number: 16091574
• Product Code: JJE
• UDI-Device Identifier: 07613336220139
• UDI-Public: 07613336220139
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K220134
• 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): 12/08/2025

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: 09793020001
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 12/08/2025
• 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