Omnipod DASH, PODS 10-PACK
Received Jul 29, 2026 · Event occurred Apr 1, 2026
Report 3014585508-2026-50902 · MDR key 50071287
Device
Generic name
Pump, Infusion, Insulin
Manufacturer
Insulet CorporationModel number
PT-000029Catalog number
POD-BLE-C1-529
Lot number
PD1U09132511
Product problems
- Fluid/Blood Leak
- Insufficient Device Problem Information
Patient
Male
- Hyperglycemia
Narrative
Additional Manufacturer Narrative
Fluid was found to leak from a tear in the exposed portion of the soft cannula. Because the timing and cause of this soft cannula damage could not be determined, it could not be conclusively determined if this damage contributed to the reported leaking during wear. Lot Release records were reviewed and the product lot met all acceptance criteria.
Description of Event or Problem
A malfunction was found in the investigation for the original report of customer not sure delivering insulin and leaking during wear at the infusion site (arm). The investigation observed a tear in the exposed portion of the soft cannula. It was also reported that the patient's blood glucose level rose to greater than 19 mmol/L (342 mg/dL) while wearing the Pod between 36 and 48 hours. As treatment, a new Pod was applied.