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

Model Number	E602
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with elecsys hiv combi pt assay on a cobas e 602 module.The sample was initially tested 3 times, and the results were 6.27 coi, 6.30 coi, and 6.51 coi, which were interpreted as "reactive".On (b)(6) 2026, the result of an aliquot of the patient sample from a different facility was "non-reactive".The repeat result was deemed correct.No questionable results were reported outside the laboratory, as all reactive results are sent out for confirmation.
Additional Manufacturer Narrative
The hiv combi pt assay lot number was 84002100 with an expiration date of 31-aug-2026.The calibration was last performed on (b)(6) 2026, and it was acceptable.The qc was within the ranges.There was no indication of a performance issue with the reagent.The sample showed no visual abnormalities.The alarm trace did not show any abnormalities.The field service engineer inspected the instrument and found no cause for the event.He performed system checks and performance testing with successful results.The instrument was performing within specifications.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 24413867
• Report Number: 1823260-2026-00628
• Device Sequence Number: 5878074
• Product Code: JJE
• UDI-Device Identifier: 04015630929764
• UDI-Public: 04015630929764
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Report Date (Section B): 02/23/2026

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/23/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BREYNA (BUDESONIDE/FORMOTEROL); BUPROPION SR (WELLBUTRIN); COZAAR (LOSARTAN); MOUNJARO (TIRZEPATIDE); PEPCID (FAMOTIDINE); PRILOSEC (OMEPRAZOLE); PROAIR HFA (ALBUTEROL SULFATE)
• Patient Age: 36 YR
• Patient Sex: Male