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

Catalog Number	05990378001
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 8000 - cobas e 602 module serial number is (b)(6).The field service engineer (fse) inspected the module and determined that the measuring cell channel had caused the event.He switched the assay to another measuring channel.He verified the module's performance with qc and precision checks.
Event or Problem Description
The initial reporter received a questionable elecsys hbsag ii result from one patient sample tested on the cobas e 602 module.The initial result from the analyzer was 0.33 cut-off index coi (non-reactive).The first repeat result from the analyzer was 1.09 coi (reactive).The second repeat result from another e602 analyzer result was 0.33 coi (non-reactive).No questionable result was reported outside the laboratory.
Additional Manufacturer Narrative
Medwatch fields d.Device identification, g1 and g4 pma / 510k (premarket numbers) updated.The field service engineer also verified that the measuring cell pathway's functions were working, flushed the flow path, and reseated the tubing.The customer did not report any other issues after the service.The investigation determined that the service actions resolved the issue.

• 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 46250-0457
• MDR Report Key: 23081731
• Report Number: 1823260-2025-03077
• Device Sequence Number: 4965716
• Product Code: JJE
• UDI-Device Identifier: 04015630929764
• UDI-Public: 04015630929764
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2025

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 Expiration Date: 02/28/2026
• Device Catalogue Number: 05990378001
• Device Lot Number: 79814201
• 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: 08/27/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 11/04/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ABILIFY 2 MG; CLONAPIN 2 MG BID; LASIX 20 MG PRN; LIPITOR 20 MG DAILY; SYMBALTA 60 MG DAILY
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 69 KG