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

Model Number	E602
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	02/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable elecsys afp assay result for three patient samples tested on a cobas e 602 module.' sample 1: the initial result was 38.23ng/ml.The repeat result was 3.25ng/ml.Sample 2: the initial result was 37.01ng/ml.The repeat result was 2.5ng/ml.Sample 3: the initial result was 148 ng/ml.The repeat result was 2.29ng/ml.The test was repeated as the initial results did not match the patients' clinical diagnosis.The repeat results were deemed correct.No erroneous results were released.

• 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: 24598268
• Report Number: 1823260-2026-00905
• Device Sequence Number: 20921576
• 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): 05/20/2026

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: 08/31/2026
• Device Model Number: E602
• Device Catalogue Number: 05990378001
• Device Lot Number: 84056801
• 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: 02/20/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 05/20/2026
• 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