Omnipod DASH Insulin Management System
Received Jul 28, 2026 · Event occurred Jul 1, 2026
Report 3014585508-2026-50443 · MDR key 50054774
Device
Generic name
Pump, Infusion, Insulin
Manufacturer
Insulet CorporationModel number
18320Catalog number
BLE-I1-529
Lot number
PD1K11302511
Product problems
- Loss of or Failure to Bond
Patient
Not reported
- Hyperglycemia
Narrative
Description of Event or Problem
It was reported the patient's blood glucose level rose to over 250 mg/dL (13.9 mmol/L) while wearing the Pod between 5 and 24 hours. The Pod reportedly fell off the infusion site on the patient¿s leg due to heat and sweating, 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.