ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL
This device is manufactured by MEDTRONIC MINIMED.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Hypoglycemia | 1 | Patient |
| 2024 | Hyperglycemia | 4 | Patient |
| 2024 | Hemorrhage/Blood Loss/Bleeding | 4 | Patient |
| 2024 | Wireless Communication Problem | 262 | Device |
| 2024 | Moisture or Humidity Problem | 1 | Device |
| 2024 | Incorrect, Inadequate or Imprecise Result or Readings | 2 | Device |
| 2024 | Inappropriate or Unexpected Reset | 1 | Device |
| 2024 | Display or Visual Feedback Problem | 10 | Device |
| 2024 | Communication or Transmission Problem | 38 | Device |
| 2024 | Calibration Problem | 5 | Device |
| 2024 | Break | 2 | Device |
| 2024 | Battery Problem | 23 | Device |
| 2024 | Appropriate Term/Code Not Available | 20 | Device |
| 2023 | Vomiting | 1 | Patient |
| 2023 | Itching Sensation | 1 | Patient |
| 2023 | Hypoglycemia | 7 | Patient |
| 2023 | Hypersensitivity/Allergic reaction | 1 | Patient |
| 2023 | Hyperglycemia | 28 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 6 | Patient |
| 2023 | Hematoma | 2 | Patient |
| 2023 | Elevated ketones/Diabetic Ketoacidosis | 1 | Patient |
| 2023 | Dizziness | 1 | Patient |
| 2023 | Bruise/Contusion | 1 | Patient |
| 2023 | Appropriate Term / Code Not Available | 1 | Patient |
| 2023 | Wireless Communication Problem | 867 | Device |
| 2023 | Use of Device Problem | 1 | Device |
| 2023 | Moisture or Humidity Problem | 4 | Device |
| 2023 | Incorrect, Inadequate or Imprecise Result or Readings | 16 | Device |
| 2023 | Inappropriate or Unexpected Reset | 4 | Device |
| 2023 | Display or Visual Feedback Problem | 50 | Device |
| 2023 | Device Markings/Labelling Problem | 1 | Device |
| 2023 | Device Alarm System | 1 | Device |
| 2023 | Computer Software Problem | 1 | Device |
| 2023 | Communication or Transmission Problem | 290 | Device |
| 2023 | Calibration Problem | 58 | Device |
| 2023 | Break | 13 | Device |
| 2023 | Battery Problem | 60 | Device |
| 2023 | Appropriate Term/Code Not Available | 47 | Device |
| 2022 | Sleep Dysfunction | 1 | Patient |
| 2022 | Hypoglycemia | 3 | Patient |
| 2022 | Hyperglycemia | 11 | Patient |
| 2022 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2022 | Wireless Communication Problem | 838 | Device |
| 2022 | Physical Resistance/Sticking | 1 | Device |
| 2022 | Packaging Problem | 1 | Device |
| 2022 | No Apparent Adverse Event | 1 | Device |
| 2022 | Moisture or Humidity Problem | 3 | Device |
| 2022 | Manufacturing, Packaging or Shipping Problem | 1 | Device |
| 2022 | Incorrect, Inadequate or Imprecise Result or Readings | 16 | Device |
| 2022 | Failure of Device to Self-Test | 4 | Device |
| 2022 | Display or Visual Feedback Problem | 46 | Device |
| 2022 | Computer Software Problem | 1 | Device |
| 2022 | Communication or Transmission Problem | 197 | Device |
| 2022 | Calibration Problem | 24 | Device |
| 2022 | Break | 19 | Device |
| 2022 | Battery Problem | 526 | Device |
| 2022 | Appropriate Term/Code Not Available | 39 | Device |
| 2021 | Hypoglycemia | 2 | Patient |
| 2021 | Hyperglycemia | 7 | Patient |
| 2021 | Wireless Communication Problem | 227 | Device |
| 2021 | Use of Device Problem | 1 | Device |
| 2021 | No Apparent Adverse Event | 1 | Device |
| 2021 | Incorrect, Inadequate or Imprecise Result or Readings | 5 | Device |
| 2021 | Inappropriate or Unexpected Reset | 1 | Device |
| 2021 | Display or Visual Feedback Problem | 5 | Device |
| 2021 | Communication or Transmission Problem | 73 | Device |
| 2021 | Calibration Problem | 2 | Device |
| 2021 | Break | 2 | Device |
| 2021 | Battery Problem | 19 | Device |
| 2021 | Appropriate Term/Code Not Available | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 1 | Device |