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 | 18 | Patient |
| 2024 | Visual Disturbances | 1 | Patient |
| 2024 | Vertigo | 1 | Patient |
| 2024 | Urticaria | 5 | Patient |
| 2024 | Urinary Tract Infection | 1 | Patient |
| 2024 | Urinary Frequency | 1 | Patient |
| 2024 | Unspecified Infection | 4 | Patient |
| 2024 | Ulcer | 1 | Patient |
| 2024 | Swelling/ Edema | 23 | Patient |
| 2024 | Skin Inflammation/ Irritation | 43 | Patient |
| 2024 | Skin Infection | 29 | Patient |
| 2024 | Scar Tissue | 1 | Patient |
| 2024 | Rash | 1 | Patient |
| 2024 | Purulent Discharge | 15 | Patient |
| 2024 | Polydipsia | 5 | Patient |
| 2024 | Pneumonia | 1 | Patient |
| 2024 | Pain | 26 | Patient |
| 2024 | Numbness | 1 | Patient |
| 2024 | Neuropathy | 1 | Patient |
| 2024 | Nausea | 16 | Patient |
| 2024 | Loss of consciousness | 8 | Patient |
| 2024 | Itching Sensation | 15 | Patient |
| 2024 | Insufficient Information | 1 | Patient |
| 2024 | Hypoglycemia | 28 | Patient |
| 2024 | Hypersensitivity/Allergic reaction | 6 | Patient |
| 2024 | Hyperglycemia | 1160 | Patient |
| 2024 | Hemorrhage/Blood Loss/Bleeding | 49 | Patient |
| 2024 | Hematoma | 1 | Patient |
| 2024 | Headache | 12 | Patient |
| 2024 | Fever | 2 | Patient |
| 2024 | Fatigue | 12 | Patient |
| 2024 | Erythema | 25 | Patient |
| 2024 | Elevated ketones/Diabetic Ketoacidosis | 25 | Patient |
| 2024 | Eczema | 3 | Patient |
| 2024 | Dyspnea | 1 | Patient |
| 2024 | Dry Mouth | 1 | Patient |
| 2024 | Dizziness | 11 | Patient |
| 2024 | Diarrhea | 2 | Patient |
| 2024 | Dehydration | 2 | Patient |
| 2024 | Convulsion/Seizure | 3 | Patient |
| 2024 | Contact Dermatitis | 3 | Patient |
| 2024 | Cognitive Changes | 1 | Patient |
| 2024 | Chest Pain | 2 | Patient |
| 2024 | Cellulitis | 3 | Patient |
| 2024 | Cardiac Arrest | 1 | Patient |
| 2024 | Burning Sensation | 3 | Patient |
| 2024 | Burn(s) | 1 | Patient |
| 2024 | Bruise/Contusion | 6 | Patient |
| 2024 | Blurred Vision | 1 | Patient |
| 2024 | Anxiety | 2 | Patient |
| 2024 | Abscess | 9 | Patient |
| 2024 | Abdominal Cramps | 3 | Patient |
| 2024 | Unintended System Motion | 3 | Device |
| 2024 | Unintended Movement | 579 | Device |
| 2024 | Thermal Decomposition of Device | 6 | Device |
| 2024 | Retraction Problem | 16 | Device |
| 2024 | Premature Activation | 46 | Device |
| 2024 | Overheating of Device | 2 | Device |
| 2024 | No Audible Prompt/Feedback | 1 | Device |
| 2024 | Material Twisted/Bent | 175 | Device |
| 2024 | Loss of or Failure to Bond | 551 | Device |
| 2024 | Intermittent Communication Failure | 1 | Device |
| 2024 | Insufficient Information | 124 | Device |
| 2024 | Inappropriate Audible Prompt/Feedback | 1 | Device |
| 2024 | Fluid/Blood Leak | 86 | Device |
| 2024 | Failure to Reset | 1 | Device |
| 2024 | Failure to Power Up | 2 | Device |
| 2024 | Failure to Fire | 251 | Device |
| 2024 | Excess Flow or Over-Infusion | 1 | Device |
| 2024 | Difficult to Insert | 75 | Device |
| 2024 | Difficult or Delayed Activation | 16 | Device |
| 2024 | Device Emits Odor | 1 | Device |
| 2024 | Communication or Transmission Problem | 1 | Device |
| 2024 | Burst Container or Vessel | 2 | Device |
| 2024 | Battery Problem | 19 | Device |
| 2024 | Application Program Problem: Medication Error | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2024 | Activation, Positioning or Separation Problem | 49 | Device |
| 2023 | Vomiting | 21 | Patient |
| 2023 | Urticaria | 3 | Patient |
| 2023 | Urinary Tract Infection | 2 | Patient |
| 2023 | Syncope/Fainting | 1 | Patient |
| 2023 | Swelling/ Edema | 15 | Patient |
| 2023 | Stroke/CVA | 2 | Patient |
| 2023 | Skin Inflammation/ Irritation | 57 | Patient |
| 2023 | Skin Infection | 42 | Patient |
| 2023 | Septic Shock | 1 | Patient |
| 2023 | Respiratory Failure | 1 | Patient |
| 2023 | Renal Failure | 1 | Patient |
| 2023 | Rash | 5 | Patient |
| 2023 | Purulent Discharge | 11 | Patient |
| 2023 | Pain | 49 | Patient |
| 2023 | Nausea | 10 | Patient |
| 2023 | Loss of consciousness | 11 | Patient |
| 2023 | Itching Sensation | 8 | Patient |
| 2023 | Irritability | 1 | Patient |
| 2023 | Insufficient Information | 2 | Patient |
| 2023 | Hypoglycemia | 22 | Patient |
| 2023 | Hypersensitivity/Allergic reaction | 4 | Patient |
| 2023 | Hyperglycemia | 1759 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 26 | Patient |
| 2023 | Hematoma | 1 | Patient |
| 2023 | Headache | 7 | Patient |
| 2023 | Fever | 5 | Patient |
| 2023 | Fatigue | 1 | Patient |
| 2023 | Extreme Exhaustion | 1 | Patient |
| 2023 | Erythema | 10 | Patient |
| 2023 | Elevated ketones/Diabetic Ketoacidosis | 31 | Patient |
| 2023 | Eczema | 2 | Patient |
| 2023 | Dizziness | 8 | Patient |
| 2023 | Diarrhea | 1 | Patient |
| 2023 | Dehydration | 11 | Patient |
| 2023 | Convulsion/Seizure | 6 | Patient |
| 2023 | Contact Dermatitis | 1 | Patient |
| 2023 | Coma | 1 | Patient |
| 2023 | Cognitive Changes | 2 | Patient |
| 2023 | Chest Pain | 4 | Patient |
| 2023 | Cellulitis | 3 | Patient |
| 2023 | Burning Sensation | 5 | Patient |
| 2023 | Burn(s) | 1 | Patient |
| 2023 | Bruise/Contusion | 7 | Patient |
| 2023 | Bacterial Infection | 4 | Patient |
| 2023 | Abscess | 5 | Patient |
| 2023 | Abrasion | 1 | Patient |
| 2023 | Abdominal Cramps | 3 | Patient |
| 2023 | Unintended System Motion | 2 | Device |
| 2023 | Unintended Movement | 1090 | Device |
| 2023 | Unintended Electrical Shock | 1 | Device |
| 2023 | Thermal Decomposition of Device | 26 | Device |
| 2023 | Smoking | 1 | Device |
| 2023 | Retraction Problem | 63 | Device |
| 2023 | Premature Discharge of Battery | 6 | Device |
| 2023 | Premature Activation | 137 | Device |
| 2023 | Overheating of Device | 61 | Device |
| 2023 | Off-Label Use | 1 | Device |
| 2023 | No Display/Image | 1 | Device |
| 2023 | Material Twisted/Bent | 366 | Device |
| 2023 | Material Split, Cut or Torn | 4 | Device |
| 2023 | Loss of or Failure to Bond | 975 | Device |
| 2023 | Loss of Power | 2 | Device |
| 2023 | Intermittent Communication Failure | 2 | Device |
| 2023 | Insufficient Information | 178 | Device |
| 2023 | Fluid/Blood Leak | 153 | Device |
| 2023 | Failure to Select Signal | 2 | Device |
| 2023 | Failure to Power Up | 2 | Device |
| 2023 | Failure to Fire | 259 | Device |
| 2023 | Failure to Charge | 2 | Device |
| 2023 | Excess Flow or Over-Infusion | 1 | Device |
| 2023 | Display Difficult to Read | 6 | Device |
| 2023 | Difficult to Insert | 134 | Device |
| 2023 | Difficult or Delayed Activation | 19 | Device |
| 2023 | Device Emits Odor | 4 | Device |
| 2023 | Crack | 1 | Device |
| 2023 | Communication or Transmission Problem | 5 | Device |
| 2023 | Charging Problem | 1 | Device |
| 2023 | Burst Container or Vessel | 3 | Device |
| 2023 | Battery Problem | 111 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2023 | Activation, Positioning or Separation Problem | 99 | Device |
| 2023 | Activation Problem | 1 | Device |
| 2022 | Vomiting | 7 | Patient |
| 2022 | Swelling/ Edema | 1 | Patient |
| 2022 | Skin Inflammation/ Irritation | 6 | Patient |
| 2022 | Skin Infection | 8 | Patient |
| 2022 | Scar Tissue | 1 | Patient |
| 2022 | Rash | 1 | Patient |
| 2022 | Purulent Discharge | 1 | Patient |
| 2022 | Pain | 2 | Patient |
| 2022 | Nausea | 6 | Patient |
| 2022 | Loss of consciousness | 3 | Patient |
| 2022 | Itching Sensation | 2 | Patient |
| 2022 | Insufficient Information | 1 | Patient |
| 2022 | Hypoglycemia | 5 | Patient |
| 2022 | Hyperglycemia | 120 | Patient |
| 2022 | Headache | 2 | Patient |
| 2022 | Fever | 8 | Patient |
| 2022 | Elevated ketones/Diabetic Ketoacidosis | 11 | Patient |
| 2022 | Eczema | 1 | Patient |
| 2022 | Contact Dermatitis | 1 | Patient |
| 2022 | Burning Sensation | 1 | Patient |
| 2022 | Bacterial Infection | 2 | Patient |
| 2022 | Abscess | 6 | Patient |
| 2022 | Abdominal Cramps | 2 | Patient |
| 2022 | Unintended System Motion | 7 | Device |
| 2022 | Unintended Movement | 650 | Device |
| 2022 | Thermal Decomposition of Device | 12 | Device |
| 2022 | Smoking | 3 | Device |
| 2022 | Retraction Problem | 24 | Device |
| 2022 | Reset Problem | 1 | Device |
| 2022 | Premature Discharge of Battery | 6 | Device |
| 2022 | Premature Activation | 136 | Device |
| 2022 | Overheating of Device | 68 | Device |
| 2022 | No Display/Image | 4 | Device |
| 2022 | Material Twisted/Bent | 448 | Device |
| 2022 | Material Split, Cut or Torn | 4 | Device |
| 2022 | Material Integrity Problem | 1 | Device |
| 2022 | Loss of or Failure to Bond | 525 | Device |
| 2022 | Loss of Data | 2 | Device |
| 2022 | Leak/Splash | 1 | Device |
| 2022 | Intermittent Communication Failure | 2 | Device |
| 2022 | Insufficient Information | 236 | Device |
| 2022 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2022 | Inappropriate or Unexpected Reset | 1 | Device |
| 2022 | Inaccurate Synchronization | 1 | Device |
| 2022 | Inaccurate Delivery | 1 | Device |
| 2022 | Fluid/Blood Leak | 125 | Device |
| 2022 | Failure to Power Up | 8 | Device |
| 2022 | Failure to Fire | 221 | Device |
| 2022 | Failure to Charge | 3 | Device |
| 2022 | Excessive Heating | 1 | Device |
| 2022 | Excess Flow or Over-Infusion | 1 | Device |
| 2022 | Erratic or Intermittent Display | 1 | Device |
| 2022 | Electrical /Electronic Property Problem | 1 | Device |
| 2022 | Difficult to Insert | 147 | Device |
| 2022 | Difficult or Delayed Activation | 11 | Device |
| 2022 | Device Emits Odor | 2 | Device |
| 2022 | Device Alarm System | 1 | Device |
| 2022 | Detachment of Device or Device Component | 1 | Device |
| 2022 | Defective Alarm | 1 | Device |
| 2022 | Data Problem | 1 | Device |
| 2022 | Computer Software Problem | 2 | Device |
| 2022 | Communication or Transmission Problem | 7 | Device |
| 2022 | Burst Container or Vessel | 1 | Device |
| 2022 | Battery Problem | 128 | Device |
| 2022 | Application Program Problem: Dose Calculation Error | 2 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2022 | Activation, Positioning or Separation Problem | 66 | Device |
| 2022 | Activation Problem | 4 | Device |
| 2021 | Stroke/CVA | 1 | Patient |
| 2021 | Hypoglycemia | 2 | Patient |
| 2021 | Hyperglycemia | 1 | Patient |
| 2021 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2021 | Coma | 1 | Patient |
| 2021 | Unintended System Motion | 5 | Device |
| 2021 | Overheating of Device | 1 | Device |
| 2021 | Material Twisted/Bent | 2 | Device |
| 2021 | Intermittent Communication Failure | 1 | Device |
| 2021 | Insufficient Information | 17 | Device |
| 2021 | Inappropriate Audible Prompt/Feedback | 1 | Device |
| 2021 | Fluid/Blood Leak | 1 | Device |
| 2021 | Failure to Fire | 1 | Device |
| 2021 | Difficult to Insert | 1 | Device |
| 2021 | Battery Problem | 1 | Device |