inforMED
MalfunctionLZG

Omnipod DASH Insulin Management System

Received Jul 31, 2026 · Event occurred May 14, 2026

Report 3014585508-2026-52095 · MDR key 50107562

Device

Generic name

Pump, Infusion, Insulin

Model number

18320

Catalog number

BLE-I1-529

Lot number

PD1U11122421

Product problems

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

Patient

Not reported

  • Hyperglycemia