inforMED
MalfunctionLZG

Omnipod DASH Insulin Management System

Received Jul 31, 2026 · Event occurred Jul 4, 2026

Report 3014585508-2026-52018 · MDR key 50105636

Device

Generic name

Pump, Infusion, Insulin

Model number

18320

Catalog number

BLE-I1-529

Lot number

PD1K09012531

Product problems

  • Loss of or Failure to Bond
  • Material Twisted/Bent
  • Unintended Movement

Patient

Male

  • Hyperglycemia