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	07/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a software issue with a navify lab operations software product.The customer alleged that glucose results for a patient sample were transmitted to their laboratory information system with a different (incorrect) identification number.
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
It was determined the cause of the issue was that when sending results to a host with the option "send grouped and separated by" set to "instrument and module," if there are three or more different instruments and modules involved and the system is processing different sample tubes, the system groups at least one of the tests to an incorrect tube within the same order.The reported allegation has been verified as a software issue in navify lab operations as the system should always send test results with the tube in which they were performed, regardless of the "send grouped and separated by" option.

• 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: 22777221
• Report Number: 1823260-2025-02440
• Device Sequence Number: 9185094
• Product Code: JQP
• UDI-Device Identifier: 07613336234402
• UDI-Public: 07613336234402
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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: 07/22/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 09/03/2025
• 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