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	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The host connectivity agent (hca) is the module that exchanges information with external systems.This exchange is made through messages in which specific information is communicated to the other system.Cobas® infinity can send and receive this information.The hca has advanced actions that allow for defining what to do with the patient and order depending on the existing information in the database.The investigation found that the message received from the host with the data for patient (b)(6) had the patient identifier: (b)(6).There was already a patient in the database with the identifier: (b)(6) for patient (b)(6).There was a patient in the database corresponding to patient (b)(6) (first name and name) but with a different patient identifier.The investigation found that the hca action in this case was: when there is a patient identifier in the database matching the one received in the message, and there is a patient with the same first name and name as the one received in the message in the database, then "use the received history without modifying demographics." in this case, the patient identifier received in the message was used to select the patient existing in the database, and it was used without changing its data.This was confirmed as a software issue.The system was configured to use the patient in the database with the same patient identifier without changing its demographics due to a documentation issue.In the user assistance of the cobas infinity version 3.02.09 it was not specifically indicated how the system behaves when both "other patient id" and "patient demographics (other)" match.In the newer versions of the user assistance, this was clarified with the sentence: "the patient id prevails when there is a discrepancy between the patient demographics and the patient id." this documentation issue has been addressed in cobas infinity versions 3.07 and above.The customer should upgrade the software to a newer version with the updated user assistance documentation.
Event or Problem Description
The initial reporter complained of an issue with cobas infinity lab core license software version 3.02.09.The customer alleged that a sample came in for one patient (patient (b)(6) but was assigned to a different patient (patient (b)(6).No patients were harmed due to this issue.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21739799
• Report Number: 1823260-2025-00962
• Device Sequence Number: 4022279
• Product Code: JQP
• UDI-Device Identifier: 07613336177129
• UDI-Public: 07613336177129
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 04/01/2025

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: 03/12/2025
• Initial Report FDA Received Date: 04/01/2025
• 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