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	08/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event was found to be caused when a sample with no initial results is queried by two different instruments and the software responds by performing the test with no dilution.When the result with an alarm configured in the alarm control is received from the first instrument, a repetition with dilution factor "dec" is generated in the software.The result from the second instrument (independent of any alarm that arrives with the result) is assigned to the repetition with "dec" dilution factor even though the dilution factor was never sent to the instrument.The reported allegation has been verified as a software issue in navify lab operations as this information is sent to the external host as it is configured to be sent in the result message and the dilution info is sent to the customer's laboratory information system configuration.
Event or Problem Description
There was an allegation of a navify lab operations software issue.It was alleged that the software is sending a dilution factor to the customer's laboratory information system which was never requested by the instrument.

• 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: 23076139
• Report Number: 1823260-2025-03051
• Device Sequence Number: 9996312
• Product Code: JQP
• UDI-Device Identifier: 07613336234402
• UDI-Public: 07613336234402
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2025

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: 09/02/2025
• Initial Report FDA Received Date: 09/17/2025
• 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