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	12/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer and regent lot number involved in the event was not provided.The investigation is ongoing.
Event or Problem Description
There was an allegation of a result issue for the benzodiazepine assay due to the navify lab operations software.A rule in the software for the assay was triggered twice.This rule transforms the result to negative if it is less than 0.Otherwise, it sets the result to positive.The option 'when value cannot be evaluated is considered false' was enabled, and the same rule was executed again.As a result, the initial outcome was negative, but since it could not be evaluated again, it was considered false, and the result was set to positive.
Additional Manufacturer Narrative
The alleged behaviour only occurred in the reported sample, and no other instance was identified.The investigation was unable to reproduce the issue in a virtual environment, and no evidence of what caused the trigger could be found.No root cause or product issue could be identified.

• 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: 23979496
• Report Number: 1823260-2026-00069
• Device Sequence Number: 14596887
• Product Code: JQP
• UDI-Device Identifier: 07613336234402
• UDI-Public: 07613336234402
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 01/09/2026

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: 10382716001
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 01/09/2026
• 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 Sex: Unknown