MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INFINITY CORE SOFTWARE; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Catalog Number	07154003001
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of an issue with cobas infinity core software version 3.03.38.The customer alleged a missing delta check flag.An example of the issue was provided for 1 patient with a psa test.On (b)(6) 2025, the psa result was 2.81, and a delta check flag was triggered based on the previous result of 5.12 on (b)(6) 2024.On (b)(6) 2026, the psa result was 4.07, and a delta check flag was not triggered based on the previous result of 2.79 on (b)(6) 2025.No unit of measure was provided for the psa test.
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
For the event on (b)(6) 2026, the investigation found that the primary units for the psa test on (b)(6) 2025, were configured as mg/ml.For the psa test on (b)(6) 2026, the primary units were configured as ng/ml.According to product labeling: "if the test for which you are configuring a delta check has a primary unit defined, this field is filled with the same unit.The delta check does not consider results expressed in a different unit from the one entered in the primary unit field of tests." since the configured units changed between samples, the system ignored the latest result for delta check purposes.The investigation did not identify a product problem.The software worked as designed.

• Brand Name: COBAS INFINITY CORE SOFTWARE
• 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: 24400884
• Report Number: 1823260-2026-00605
• Device Sequence Number: 10113312
• Product Code: JQP
• UDI-Device Identifier: 04015630936007
• UDI-Public: 04015630936007
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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): 03/18/2026

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 Catalogue Number: 07154003001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/18/2026
• 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 Age: 66 YR
• Patient Sex: Male