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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation found that due to a software issue, when multiple reports are printed at the same time, the software may generate invalid xsl files.When this happens, reports using this design file are no longer generated/printed.To restore printing, the user can save the report design to enable printing.
Event or Problem Description
There was an allegation that reports were not available due to an issue with the navify lab operations software.Allegedly, the doctors could not retrieve the blood gas test results from a rapidpoint instrument for a patient.At 12:24, an order for blood gas testing was generated.This was registered correctly in navify ® lab operations, and the results for the order were received in navify lab operations.Between 12:59 and 13:11, there were four attempts to preview the order through the report's preview web service.Allegedly, a pdf was not generated due to a software issue.At 13:12, the results for the order were manually validated by a laboratory user.During this time period, the results remained visually available in the instrument and in the software itself.

• 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: 23540645
• Report Number: 1823260-2025-04612
• Device Sequence Number: 21275964
• Product Code: JQP
• UDI-Device Identifier: 07613336234402
• UDI-Public: 07613336234402
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• 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): 11/13/2025

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: 10/23/2025
• Initial Report FDA Received Date: 11/13/2025
• 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