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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
1.Summary of investigation results: the service maintenance actions performed by the fse resolved the issue.2.Summary of follow up/corrective actions taken: the field service engineer (fse) found black particles in the main pump tubing and replaced multiple solenoid valves, the degassed tank, and the main pump head, cleaned filters, and adjusted the water pressure.An instrument check was performed successfully.3.Device returned to manufacturer? no.4.Device labeled "for single use? no.5.Device reprocessed and reused? no.
Event or Problem Description
1.Describe the event: there was an allegation of questionable elecsys t4 results for 19 patient samples on a cobas 8000 - cobas e 602 module.2.Patient age range: asku.3.Patient weight range: asku.4.Patient sex breakdown: asku.5.Patient race breakdown: asku.6.Patient ethnicity breakdown: asku.

• 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: 25000458
• Report Number: 1823260-2026-01621
• Device Sequence Number: 15635689
• Product Code: JJE
• UDI-Device Identifier: 04015630929764
• UDI-Public: 04015630929764
• Combination Product (Y/N): N
• PMA/510(K) Number: K100853
• Exemption Number: VMSR
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/27/2026

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?: No
• Device Model Number: E602
• Device Catalogue Number: 05990378001
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown