inforMED
MalfunctionLZG

Omnipod DASH Insulin Management System

Received Jul 27, 2026 · Event occurred Jun 15, 2026

Report 3014585508-2026-48623 · MDR key 50000072

Device

Generic name

Pump, Infusion, Insulin

Model number

18320

Catalog number

BLE-I1-529

Lot number

PD1K08272531

Product problems

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

Patient

Male

  • Hyperglycemia