MAUDE Adverse Event Report: ROCHE DIAGNOSTICS NAVIFY LAB OPERATIONS; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Catalog Number	10382716001
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During the investigation, it was found that the allegation is related to a software issue leading to the unexpected outcome.The direct root cause is that the system is not modifying the result according to the range result modification defined when a flag is sent by either the cobas 5800 or the cobas 8800.As a workaround, alphanumeric result modification can be configured, since the saved result is alphanumeric.Once enabled, all results identified as flags will be modified accordingly.
Event or Problem Description
Roche diagnostics received an allegation of incorrect software behavior.The module in question communicates with the instruments connected to cobas® infinity central lab.Its function is to exchange information with any instrument connected to the lis.Test results sent by an instrument can be replaced with a specific value.Result by range replacement can be configured to be triggered when the received result falls between two values, has one or more assigned instrument alarms, or includes dilution information.These three conditions can be configured together for the same test, functioning as an and parameter, or separately, functioning as an or parameter.The issue is related to a software problem leading to an unexpected behavior.When the range result modification is configured for a specific flag, and results are sent with that same flag, the system does not trigger the modification, and instead saves the flag as the result.No patients were harmed due to this issue.
Additional Manufacturer Narrative
Medwatch field h6.Adverse event problem, investigation findings, and investigation conclusion codes were updated.

• Brand Name: NAVIFY LAB OPERATIONS
• 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: 22106323
• Report Number: 1823260-2025-01656
• Device Sequence Number: 7201763
• Product Code: JQP
• UDI-Device Identifier: 07613336234402
• UDI-Public: 07613336234402
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2025

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: 10382716001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 07/17/2025
• 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