MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 602 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number	E602
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot numbers were requested but were not provided.The field service engineer (fse) found the cause was related to the pinch valves.After replacement and subsequently an air purge, mechanical check, and measuring cell preparations, the instrument was found to be working according to specifications.Following the fse intervention, no further issues were observed.The investigation determined that the service actions resolved the issue.
Event or Problem Description
There was an allegation of questionable elecsys ft3 iii and elecsys tsh assay results for multiple patient samples tested on a cobas 8000 e 602 module.Please refer to the attachment pt-(b)(6) for the table containing the questionable results.

• Brand Name: COBAS E 602 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: 25285845
• Report Number: 1823260-2026-02067
• Device Sequence Number: 21276360
• Product Code: JJE
• UDI-Device Identifier: 04015630929764
• UDI-Public: 04015630929764
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K100853
• 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): 05/26/2026

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 Model Number: E602
• Device Catalogue Number: 05990378001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 05/26/2026
• 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