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

Model Number	E602
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 602 module serial number is (b)(6).The alarm trace did not indicate any issues.The investigation found that the event was consistent with the dirt and crystalline material from the sample probe and gripper falling into the reaction cup during the assay.The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable elecsys cea result from one patient sample tested on the cobas e 602 module.The initial result was 5.22 ng/ml.The repeat result was 1.07 ng/ml.The repeat result was deemed correct.
Additional Manufacturer Narrative
Medwatch sections d.Device identification, d.Manufacturer info, g contact office-manufacturing site (continued g1), and medwatch field g4 pma / 510k (premarket numbers) updated.The customer stated that the qcs were within the specified ranges.The investigation determined that incomplete or incorrect customer maintenance caused the event (excessive dirt and crystalline material in the sample probe, contaminating the gripper).Product labeling states: "daily maintenance of the e 602 module cleaning probes and nozzles of the e 602 module - to ensure that the instrument measures accurately, you must clean the sample probe, reagent probe, the nozzles of the pre-wash area, and the ecl sipper nozzles." the investigation did not identify a product problem.

• 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: 24458025
• Report Number: 1823260-2026-00715
• Device Sequence Number: 9310413
• Product Code: JJE
• UDI-Device Identifier: 04015630929764
• UDI-Public: 04015630929764
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 03/26/2026

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 Expiration Date: 06/30/2026
• Device Model Number: E602
• Device Catalogue Number: 05990378001
• Device Lot Number: 85460200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 03/01/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/26/2026
• 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