Omnipod DASH Insulin Management System
Received Jul 27, 2026 · Event occurred Jun 29, 2026
Report 3014585508-2026-48721 · MDR key 50003139
Device
Generic name
Pump, Infusion, Insulin
Manufacturer
Insulet CorporationModel number
18320Catalog number
BLE-I1-529
Lot number
PD1K10112511
Product problems
- Loss of or Failure to Bond
- Unintended Movement
Patient
Not reported
- Hyperglycemia
Narrative
Description of Event or Problem
It was reported the patient's blood glucose level rose to greater than 400 mg/dL while wearing the Pod. The Pod reportedly fell off the infusion site (belly), causing the cannula to dislodge after swimming. The Pod was disposed and as treatment, a new Pod was applied.
Additional Manufacturer Narrative
According to the complainant the device will not be available for investigation because it was discarded. We are unable to determine if any product condition could have contributed to the reported event. Lot Release records were reviewed, and the product lot met all acceptance criteria.