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

Catalog Number	05990378001
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ca 19-9 reagent lot number was 85726300 with an expiration date of 30-nov-2026.The ferritin reagent lot number was 82140600 with an expiration date of 31-jan-2026.The qc from the day before the event was acceptable but had an error on the day of the event.On (b)(6) 2025, the customer noticed a leak in the pinch tubing.The customer changed the pinch tubing and performed qc with acceptable results.On 12-oct-2025, the field service engineer checked the instrument and found no visual leaks on the pinch tubing.He then performed precision studies and qc, and they were within specifications.He verified that the instrument was performing within specifications.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 2 patients' samples tested with elecsys ca 19-9 assay and 2 patients' samples tested with elecsys ferritin assay on a cobas 8000 - cobas e 602 module.Sample 1 and sample 2 were tested for ca19-9: sample 1: initial result: 198.4 u/ml.Repeat result: <0.600 u/ml (
Additional Manufacturer Narrative
The calibrations for ca 19-9 and ferritin were last performed on (b)(6) 2025, and they were acceptable.The provided spin time was shorter than recommended, and the spin speed was faster than recommended.The service actions performed by the field service engineer resolved the issue.No further issues were reported after the service visit.

• 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: 23476872
• Report Number: 1823260-2025-04500
• Device Sequence Number: 16083700
• Product Code: JJE
• UDI-Device Identifier: 04015630929764
• UDI-Public: 04015630929764
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 11/21/2025

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 Catalogue Number: 05990378001
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 11/21/2025
• 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
• Patient Sex: Unknown