inforMED
MalfunctionLZG

Omnipod DASH Insulin Management System

Received Jul 29, 2026 · Event occurred Jun 29, 2026

Report 3014585508-2026-50788 · MDR key 50065809

Device

Generic name

Pump, Infusion, Insulin

Model number

18320

Catalog number

BLE-I1-529

Lot number

PD1K09022521

Product problems

  • Loss of or Failure to Bond
  • Fluid/Blood Leak
  • Unintended Movement

Patient

Female

  • Hemorrhage/Blood Loss/Bleeding
  • Hyperglycemia