Omnipod DASH, PODS 10-PACK
Received Jul 31, 2026 · Event occurred Jul 11, 2026
Report 3014585508-2026-51858 · MDR key 50100992
Device
Generic name
Pump, Infusion, Insulin
Manufacturer
Insulet CorporationModel number
PT-000029Catalog number
POD-BLE-C1-529
Lot number
PD1K01282641
Product problems
- Fluid/Blood Leak
- Material Split, Cut or Torn
Patient
Male
- Hyperglycemia
Narrative
Description of Event or Problem
It was reported the patient's blood glucose level rose to 504 mg/dL (28 mmol/L) while wearing the Pod between 24 and 36 hours on the arm. Reportedly the Pod's cannula was found damaged, resulting in insulin not being delivered into the body. The patient noted insulin was leaking inside the Pod and could be seen in the viewing window. As treatment, a new Pod was applied. The faulty Pod was discarded.
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.