MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INFINITY LAB CORE LICENSE 3.X; CALCULATOR/DATA PROCESSING MODULE FOR CLINICAL USE

Catalog Number	09180443001
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of an issue with the cobas infinity lab core license version 3.10.03.The customer alleged that an incorrect patient result was displayed from the patient history tab.The customer was checking the patient result history tab for a patient; however, the results shown were for a different patient.The patient was not harmed due to this issue.
Additional Manufacturer Narrative
The patient history tab displays a user-configured number of previous orders for the patient associated with the shown order, provided there is at least one previous order to be displayed.The patient table contains the headers, including the order id and the order date, and the results.The first order listed in the table corresponds to the current order displayed on the validation screen.The investigation determined that after moving to a different order in the validation screen, the headers are refreshed and use the information of the new patient in the screen, however, the results part is not refreshed and the results are the same shown for the previous order, which is likely not belonging to the same patient of the order being currently shown in the screen.The investigation determined that the software is not handling some scenarios of moving between orders in a work area correctly, caused by a code that was not executed or an error when the code was executed.The investigation verified the event as a software issue in the cobas infinity.

• Brand Name: COBAS INFINITY LAB CORE LICENSE 3.X
• Common Device Name: CALCULATOR/DATA PROCESSING MODULE FOR CLINICAL USE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23310264
• Report Number: 1823260-2025-04221
• Device Sequence Number: 14699571
• Product Code: JQP
• UDI-Device Identifier: 07613336177129
• UDI-Public: 07613336177129
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 10/16/2025

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: 09180443001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 10/16/2025
• 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 Age: 79 YR
• Patient Sex: Male
• Patient Race: Asian