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

Catalog Number	05990378001
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient's sample tested with elecsys troponin t hs stat assay on the cobas e 602 module.Four different blood draws from the same patient were tested.Sample 1 was tested at 8:00 pm: 9 ng/l.Sample 2 was tested at 11:00 pm: 32 ng/l.On (b)(6) 2025: sample 3 was tested at 2 am: 12 ng/l.Sample 4 was tested at 8 am: 12 ng/l.Sample 2's results were questioned, prompting the rerun.The repeat results are: 32 ng/l, 28 ng/l, and 14 ng/l.
Additional Manufacturer Narrative
The troponin t hs stat reagent lot number was 869586.The expiration date was not provided.Samples 2 was collected using a thrombin tube.The investigation is ongoing.
Additional Manufacturer Narrative
The customer maintenance was executed per the specifications.The centrifugation duration was short.A general reagent or analyzer problem can be excluded because the qc prior to the event was within the ranges, and no relevant alarm occurred.The investigation did not identify a product problem.The cause of the event was consistent with a sample quality 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
• MDR Report Key: 23632034
• Report Number: 1823260-2025-04801
• Device Sequence Number: 21154875
• Product Code: JJE
• UDI-Device Identifier: 04015630929764
• UDI-Public: 04015630929764
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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): 12/22/2025

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: 10/30/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/22/2025
• 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