MAUDE Adverse Event Report: Roche Diagnostics cobas e 602 Module; IMMUNOCHEMISTRY ANALYZER

Model Number	e602
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 2 patients' samples tested with elecsys troponin t gen 5 stat assay and 1 patient sample tested with elecsys ferritin - 200 kit assay on a cobas e 602 module.Patient (b)(6): troponin t: initial result: 9.97 ng/l.Repeat result: 58.69 ng/l (tested on a different e 602 module).Patient (b)(6): troponin t: initial result: <6 ng/l.Repeat result: 14.68 ng/l (tested on a different e 602 module).Patient (b)(6): ferritin: initial result: 6.54 ng/ml.Repeat result: 25.1 ng/ml.The emergency room physician questioned the initial results, prompting a repeat of the samples for patient 1, patient 2, and patient 3 on (b)(6)2026.The repeat results were deemed to be correct.
Additional Manufacturer Narrative
The troponin t gen 5 stat reagent lot number was 92446502 with an expiration date of 30-apr-2027.The ferritin reagent lot number was 87816403 with an expiration date of 31-oct-2026.The field service engineer checked the module and performed some service actions.The investigation is ongoing.

• Brand Name: cobas e 602 Module
• Common Device Name: IMMUNOCHEMISTRY ANALYZER
• Manufacturer (Section D): Roche Diagnostics; 9115 hague road; indianapolis IN 46250 -045
• 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: 50931496
• Report Number: 1823260-2026-04003
• Device Sequence Number: 9734361
• Product Code: JJE
• UDI-Device Identifier: 04015630929764
• UDI-Public: 04015630929764
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K100853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: e602
• Device Catalogue Number: 05990378001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/06/2026
• Initial Report FDA Received Date: 09/29/2026
• 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