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 | 9 | Patient |
| 2024 | Urinary Frequency | 1 | Patient |
| 2024 | Skin Inflammation/ Irritation | 3 | Patient |
| 2024 | Skin Infection | 1 | Patient |
| 2024 | Scar Tissue | 1 | Patient |
| 2024 | Rash | 3 | Patient |
| 2024 | Polydipsia | 2 | Patient |
| 2024 | Pain | 6 | Patient |
| 2024 | Nausea | 9 | Patient |
| 2024 | Hypoglycemia | 4 | Patient |
| 2024 | Hyperglycemia | 245 | Patient |
| 2024 | Hemorrhage/Blood Loss/Bleeding | 7 | Patient |
| 2024 | Headache | 2 | Patient |
| 2024 | Fatigue | 3 | Patient |
| 2024 | Erythema | 2 | Patient |
| 2024 | Elevated ketones/Diabetic Ketoacidosis | 8 | Patient |
| 2024 | Dizziness | 1 | Patient |
| 2024 | Depression | 1 | Patient |
| 2024 | Dehydration | 1 | Patient |
| 2024 | Convulsion/Seizure | 1 | Patient |
| 2024 | Bruise/Contusion | 1 | Patient |
| 2024 | Alteration in Body Temperature | 1 | Patient |
| 2024 | Abscess | 1 | Patient |
| 2024 | Abdominal Cramps | 1 | Patient |
| 2024 | Use of Device Problem | 1 | Device |
| 2024 | Unintended Movement | 113 | Device |
| 2024 | Retraction Problem | 3 | Device |
| 2024 | Premature Activation | 19 | Device |
| 2024 | Off-Label Use | 1 | Device |
| 2024 | Material Twisted/Bent | 45 | Device |
| 2024 | Loss of or Failure to Bond | 104 | Device |
| 2024 | Insufficient Information | 14 | Device |
| 2024 | Inappropriate Audible Prompt/Feedback | 1 | Device |
| 2024 | Fluid/Blood Leak | 28 | Device |
| 2024 | Failure to Fire | 50 | Device |
| 2024 | Difficult to Insert | 15 | Device |
| 2024 | Difficult or Delayed Activation | 9 | Device |
| 2024 | Communication or Transmission Problem | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2024 | Activation, Positioning or Separation Problem | 19 | Device |
| 2023 | Vomiting | 2 | Patient |
| 2023 | Swelling/ Edema | 1 | Patient |
| 2023 | Skin Inflammation/ Irritation | 5 | Patient |
| 2023 | Skin Infection | 2 | Patient |
| 2023 | Polydipsia | 1 | Patient |
| 2023 | Pain | 12 | Patient |
| 2023 | Nausea | 2 | Patient |
| 2023 | Loss of consciousness | 2 | Patient |
| 2023 | Itching Sensation | 2 | Patient |
| 2023 | Hypoglycemia | 4 | Patient |
| 2023 | Hyperglycemia | 309 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 8 | Patient |
| 2023 | Fluid Discharge | 2 | Patient |
| 2023 | Erythema | 2 | Patient |
| 2023 | Elevated ketones/Diabetic Ketoacidosis | 8 | Patient |
| 2023 | Dysphasia | 1 | Patient |
| 2023 | Dry Mouth | 1 | Patient |
| 2023 | Dizziness | 1 | Patient |
| 2023 | Diarrhea | 1 | Patient |
| 2023 | Convulsion/Seizure | 1 | Patient |
| 2023 | Chest Pain | 1 | Patient |
| 2023 | Cellulitis | 1 | Patient |
| 2023 | Bacterial Infection | 1 | Patient |
| 2023 | Anxiety | 1 | Patient |
| 2023 | Abscess | 1 | Patient |
| 2023 | Unintended Movement | 149 | Device |
| 2023 | Retraction Problem | 20 | Device |
| 2023 | Premature Activation | 35 | Device |
| 2023 | Material Twisted/Bent | 99 | Device |
| 2023 | Material Split, Cut or Torn | 3 | Device |
| 2023 | Loss of or Failure to Bond | 127 | Device |
| 2023 | Insufficient Information | 25 | Device |
| 2023 | Fluid/Blood Leak | 44 | Device |
| 2023 | Failure to Fire | 78 | Device |
| 2023 | Difficult to Insert | 30 | Device |
| 2023 | Difficult or Delayed Activation | 8 | Device |
| 2023 | Device Alarm System | 1 | Device |
| 2023 | Communication or Transmission Problem | 1 | Device |
| 2023 | Activation, Positioning or Separation Problem | 31 | Device |
| 2022 | Stroke/CVA | 1 | Patient |
| 2022 | Loss of consciousness | 1 | Patient |
| 2022 | Hypoglycemia | 2 | Patient |
| 2022 | Hyperglycemia | 25 | Patient |
| 2022 | Unintended Movement | 97 | Device |
| 2022 | Thermal Decomposition of Device | 1 | Device |
| 2022 | Retraction Problem | 4 | Device |
| 2022 | Premature Activation | 26 | Device |
| 2022 | Material Twisted/Bent | 87 | Device |
| 2022 | Material Split, Cut or Torn | 1 | Device |
| 2022 | Loss of or Failure to Bond | 69 | Device |
| 2022 | Insufficient Information | 25 | Device |
| 2022 | Fluid/Blood Leak | 31 | Device |
| 2022 | Failure to Fire | 34 | Device |
| 2022 | Explosion | 1 | Device |
| 2022 | Difficult to Insert | 38 | Device |
| 2022 | Difficult or Delayed Activation | 2 | Device |
| 2022 | Detachment of Device or Device Component | 1 | Device |
| 2022 | Communication or Transmission Problem | 2 | Device |
| 2022 | Activation, Positioning or Separation Problem | 25 | Device |
| 2022 | Activation Problem | 1 | Device |
| 2021 | Insufficient Information | 1 | Device |