Omnipod DASH Insulin Management System
Received Jul 28, 2026 · Event occurred Jun 27, 2026
Report 3014585508-2026-50579 · MDR key 50059791
Device
Generic name
Pump, Infusion, Insulin
Manufacturer
Insulet CorporationModel number
18320Catalog number
BLE-I1-529
Lot number
PD1K10082521
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 250 mg/dL while wearing the Pod between 37 and 48 hours. The Pod reportedly fell off the infusion site (arm), causing the cannula to dislodge. As treatment, a new Pod was applied.
Additional Manufacturer Narrative
The device has not been returned/received to date. If the device is received, a supplemental report will be submitted with the investigation results. 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.