MalfunctionQYV

GENIUS DIGITAL DIAGNOSTICS SYSTEM

Received May 26, 2026 · Event occurred May 6, 2026

Report 1222780-2026-00332 · MDR key 25280577

Device

Generic name

Genius Digital Imager

Manufacturer

Hologic, Inc.

Model number

GENIUS CAPITAL

Catalog number

PRD-05815

Product problems

Therapeutic or Diagnostic Output Failure

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

CUSTOMER REPORTED A DISCREPANCY IN DIAGNOSIS DURING A COMPARISON BETWEEN SYSTEMS AT THE SITE. THE CASE WAS INTERPRETED AS NEGATIVE ON THE GENIUS¿ DIGITAL DIAGNOSTICS SYSTEM AND POSITIVE ON THE IMAGER SYSTEM BY CYTOSCREENERS AND PATHOLOGISTS. NO DELAY IN PATIENT DIAGNOSIS OCCURRED. INTERNAL INVESTIGATION IS ONGOING AND RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT.