ROCHE DIGITAL PATHOLOGY DX /NAVIFY® DIGITAL PATHOLOGY (CLOUD)
Received Jul 10, 2026 · Event occurred Jun 15, 2026
Report 2028492-2026-02791 · MDR key 25780458
Device
Generic name
Whole Slide Imaging System
Manufacturer
Ventana Medical Systems Inc.Catalog number
09453733001
Product problems
- Computer Operating System Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE INITIAL REPORTER ALLEGED AN ISSUE WITH THE ROCHE DIGITAL PATHOLOGY DX /NAVIFY® DIGITAL PATHOLOGY (CLOUD) SOFTWARE.THE CUSTOMER ALLEGES THAT A SOFTWARE ISSUE LEADS TO THE INCORRECT ASSIGNMENT OF PATIENTS' SURNAMES, DATES OF BIRTH, AGES, AND GENDER. THE SOFTWARE ISSUE LEADS TO WRONG OR MISSING INFORMATION AVAILABLE FOR PATIENTS OR HEALTHCARE PROVIDERS. THE SOFTWARE CAUSED THE PATIENT INFORMATION TO SHOW AS "XXXX". WHEN THE CUSTOMER IS MANUALLY CREATING THE CASES AND SAVING THE INFORMATION WITH THE PATIENT DATA, IT WILL SAVE, BUT IMMEDIATELY SHOW AS "XXXXXX" FOR THE PATIENT INFORMATION. THE CUSTOMER ALLEGED THAT THIS CAUSES DELAYS FOR THEM BECAUSE THEY DO NOT KNOW WHICH PATIENT IS ASSIGNED TO WHICH CASE, AND THEY HAVE TO REFERENCE THEIR LABORATORY INFORMATION SYSTEM.
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING.