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	06/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
We received an allegation of an issue with the cobas infinity lab core license software version 3.03.15.The customer alleged that the software overcalculated the value for the eosinophils test, resulting in an incorrect result.Allegedly, after completing the validation and transmission process, the original result is transmitted from the instrument again as a multiplied result.This significantly higher result is not validated, as it is not compatible with the other results.
Additional Manufacturer Narrative
The cobas infinity software allows for the creation of customized rules.The software automatically triggers the corresponding actions if certain conditions are met.The customer used an instrument-test context rule, which is designed to automate actions based on events related to specific tests from instrument messages.The investigation was able to reproduce the customer's allegation.When results are sent from an instrument with the "overwrite test result" option set to "yes, except when medically validated", and the order contains tests that are already medically validated, the rule engine still evaluates rules that affect these medically validated tests.If the conditions of these rules are met, the rule is triggered and its corresponding action is executed.If the action involves modifying a test result, the medically validated result is devalidated and modified per the rule¿s action.The investigation confirmed this as a software issue, as the rule engine should not evaluate rules when results are received from an instrument with the "overwrite test result" option set to "yes, except when medically validated", and the results are already medically validated.

• 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: 22608831
• Report Number: 1823260-2025-02290
• Device Sequence Number: 9603718
• Product Code: JQP
• UDI-Device Identifier: 07613336177129
• UDI-Public: 07613336177129
• Combination Product (Y/N): N
• Initial Reporter Country: DR
• 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,Followup
• Report Date (Section B): 08/18/2025

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): Follow-Up
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 08/18/2025
• 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