MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 E601 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number	E601
Medical Device Problem Codes	False Positive Result (1227); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys hbsag ii results from the cobas 6000 e601 module.Allegedly, there were "a few samples" with hbsag results of approximately 1.37 coi (reactive).Suspecting an issue, the customer re-ran the tests on another cobas e 601 system, which yielded non-reactive results.No specific data was provided.
Additional Manufacturer Narrative
The reagent lot number was 81282601.The expiration date was not provided.The investigation found there was overdue maintenance.The customer had stopped operating the system for a period of time.The replacement of the measuring cell and other customer maintenance were not performed prior to the customer resuming operation of the analyzer.The investigation determined that the event was due to the missing/overdue maintenance actions.

• Brand Name: COBAS 6000 E601 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: 25040364
• Report Number: 1823260-2026-01699
• Device Sequence Number: 9580396
• Product Code: JJE
• UDI-Device Identifier: 04015630924714
• UDI-Public: 04015630924714
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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): 04/30/2026

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: E601
• Device Catalogue Number: 04745922001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 04/30/2026
• 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