PUMP, INFUSION, INSULIN
This device is manufactured by INSULET CORPORATION.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Vomiting | 2 | Patient |
| 2024 | Unspecified Infection | 1 | Patient |
| 2024 | Swelling/ Edema | 1 | Patient |
| 2024 | Skin Inflammation/ Irritation | 4 | Patient |
| 2024 | Skin Infection | 3 | Patient |
| 2024 | Skin Erosion | 1 | Patient |
| 2024 | Peeling | 1 | Patient |
| 2024 | Pain | 4 | Patient |
| 2024 | Nausea | 1 | Patient |
| 2024 | Loss of consciousness | 1 | Patient |
| 2024 | Itching Sensation | 1 | Patient |
| 2024 | Hyperglycemia | 139 | Patient |
| 2024 | Hemorrhage/Blood Loss/Bleeding | 3 | Patient |
| 2024 | Headache | 2 | Patient |
| 2024 | Fever | 1 | Patient |
| 2024 | Fatigue | 1 | Patient |
| 2024 | Erythema | 2 | Patient |
| 2024 | Elevated ketones/Diabetic Ketoacidosis | 7 | Patient |
| 2024 | Dizziness | 1 | Patient |
| 2024 | Cognitive Changes | 1 | Patient |
| 2024 | Cellulitis | 1 | Patient |
| 2024 | Burning Sensation | 1 | Patient |
| 2024 | Bruise/Contusion | 1 | Patient |
| 2024 | Blurred Vision | 1 | Patient |
| 2024 | Abscess | 1 | Patient |
| 2024 | Unintended Movement | 25 | Device |
| 2024 | Premature Activation | 8 | Device |
| 2024 | Material Twisted/Bent | 57 | Device |
| 2024 | Loss of or Failure to Bond | 20 | Device |
| 2024 | Insufficient Information | 13 | Device |
| 2024 | Fluid/Blood Leak | 8 | Device |
| 2024 | Failure to Fire | 37 | Device |
| 2024 | Difficult to Insert | 12 | Device |
| 2024 | Difficult or Delayed Activation | 9 | Device |
| 2024 | Activation, Positioning or Separation Problem | 8 | Device |
| 2023 | Vomiting | 6 | Patient |
| 2023 | Skin Inflammation/ Irritation | 4 | Patient |
| 2023 | Skin Infection | 8 | Patient |
| 2023 | Rash | 1 | Patient |
| 2023 | Purulent Discharge | 4 | Patient |
| 2023 | Pain | 6 | Patient |
| 2023 | Nausea | 2 | Patient |
| 2023 | Loss of consciousness | 2 | Patient |
| 2023 | Hypoglycemia | 4 | Patient |
| 2023 | Hyperglycemia | 138 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 5 | Patient |
| 2023 | Headache | 1 | Patient |
| 2023 | Erythema | 3 | Patient |
| 2023 | Elevated ketones/Diabetic Ketoacidosis | 3 | Patient |
| 2023 | Dizziness | 1 | Patient |
| 2023 | Convulsion/Seizure | 1 | Patient |
| 2023 | Bruise/Contusion | 1 | Patient |
| 2023 | Abdominal Cramps | 1 | Patient |
| 2023 | Unintended Movement | 39 | Device |
| 2023 | Retraction Problem | 1 | Device |
| 2023 | Premature Activation | 17 | Device |
| 2023 | Material Twisted/Bent | 64 | Device |
| 2023 | Loss of or Failure to Bond | 31 | Device |
| 2023 | Insufficient Information | 24 | Device |
| 2023 | Fluid/Blood Leak | 18 | Device |
| 2023 | Failure to Fire | 32 | Device |
| 2023 | Difficult to Insert | 14 | Device |
| 2023 | Difficult or Delayed Activation | 4 | Device |
| 2023 | Burst Container or Vessel | 1 | Device |
| 2023 | Activation, Positioning or Separation Problem | 6 | Device |
| 2022 | Skin Inflammation/ Irritation | 1 | Patient |
| 2022 | Skin Infection | 1 | Patient |
| 2022 | Pain | 1 | Patient |
| 2022 | Hyperglycemia | 9 | Patient |
| 2022 | Cellulitis | 1 | Patient |
| 2022 | Unintended Movement | 35 | Device |
| 2022 | Premature Activation | 16 | Device |
| 2022 | Material Twisted/Bent | 43 | Device |
| 2022 | Loss of or Failure to Bond | 30 | Device |
| 2022 | Insufficient Information | 7 | Device |
| 2022 | Fluid/Blood Leak | 6 | Device |
| 2022 | Failure to Fire | 15 | Device |
| 2022 | Difficult to Insert | 12 | Device |
| 2022 | Activation, Positioning or Separation Problem | 8 | Device |