Omnipod DASH Insulin Management System
Received Jul 31, 2026 · Event occurred Jun 2, 2026
Report 3014585508-2026-51868 · MDR key 50101276
Device
Generic name
Pump, Infusion, Insulin
Manufacturer
Insulet CorporationModel number
18320Catalog number
BLE-I1-529
Lot number
PD1K05302521
Product problems
- Activation, Positioning or Separation Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported by the caregiver that there was a problem with the needle mechanism. Blood glucose levels were not reported. The duration of Pod wear was not provided. No further information regarding Pod is available. There was no report of medical intervention.
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.