Omnipod DASH, PODS 10-PACK
Received Jul 31, 2026 · Event occurred Jul 17, 2026
Report 3014585508-2026-51886 · MDR key 50101720
Device
Generic name
Pump, Infusion, Insulin
Manufacturer
Insulet CorporationModel number
PT-000029Catalog number
POD-BLE-C1-529
Lot number
PD1K01282621
Product problems
- Premature Activation
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported the needle mechanism had fully deployed before the Pod was able to be used. No impact to the patient's glucose level was reported. The pod was not worn. Treatment details not provided.
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.