ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL
This device is manufactured by MEDTRONIC, MEDTRONIC MINIMED.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Hyperglycemia | 3 | Patient |
| 2024 | Hemorrhage/Blood Loss/Bleeding | 4 | Patient |
| 2024 | Wireless Communication Problem | 194 | Device |
| 2024 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2024 | Inappropriate or Unexpected Reset | 1 | Device |
| 2024 | Display or Visual Feedback Problem | 5 | Device |
| 2024 | Communication or Transmission Problem | 27 | Device |
| 2024 | Calibration Problem | 6 | Device |
| 2024 | Break | 1 | Device |
| 2024 | Battery Problem | 6 | Device |
| 2024 | Appropriate Term/Code Not Available | 9 | Device |
| 2023 | Hypoglycemia | 2 | Patient |
| 2023 | Hyperglycemia | 9 | Patient |
| 2023 | Bruise/Contusion | 1 | Patient |
| 2023 | Wireless Communication Problem | 621 | Device |
| 2023 | Moisture or Humidity Problem | 2 | Device |
| 2023 | Incorrect, Inadequate or Imprecise Result or Readings | 13 | Device |
| 2023 | Inappropriate or Unexpected Reset | 2 | Device |
| 2023 | Failure of Device to Self-Test | 2 | Device |
| 2023 | Display or Visual Feedback Problem | 28 | Device |
| 2023 | Communication or Transmission Problem | 235 | Device |
| 2023 | Calibration Problem | 48 | Device |
| 2023 | Break | 4 | Device |
| 2023 | Battery Problem | 35 | Device |
| 2023 | Appropriate Term/Code Not Available | 25 | Device |
| 2022 | Skin Inflammation/ Irritation | 1 | Patient |
| 2022 | Hypoglycemia | 4 | Patient |
| 2022 | Hyperglycemia | 13 | Patient |
| 2022 | Bruise/Contusion | 1 | Patient |
| 2022 | Wireless Communication Problem | 1216 | Device |
| 2022 | Packaging Problem | 1 | Device |
| 2022 | No Apparent Adverse Event | 9 | Device |
| 2022 | Moisture or Humidity Problem | 3 | Device |
| 2022 | Material Integrity Problem | 1 | Device |
| 2022 | Incorrect, Inadequate or Imprecise Result or Readings | 12 | Device |
| 2022 | Failure of Device to Self-Test | 1 | Device |
| 2022 | Display or Visual Feedback Problem | 67 | Device |
| 2022 | Communication or Transmission Problem | 325 | Device |
| 2022 | Calibration Problem | 35 | Device |
| 2022 | Break | 41 | Device |
| 2022 | Battery Problem | 806 | Device |
| 2022 | Appropriate Term/Code Not Available | 59 | Device |
| 2021 | Skin Inflammation/ Irritation | 1 | Patient |
| 2021 | Skin Erosion | 1 | Patient |
| 2021 | Rash | 1 | Patient |
| 2021 | Pain | 1 | Patient |
| 2021 | Hypoglycemia | 5 | Patient |
| 2021 | Hyperglycemia | 17 | Patient |
| 2021 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2021 | Erythema | 1 | Patient |
| 2021 | Bruise/Contusion | 1 | Patient |
| 2021 | Wireless Communication Problem | 993 | Device |
| 2021 | Patient Device Interaction Problem | 2 | Device |
| 2021 | No Apparent Adverse Event | 11 | Device |
| 2021 | Moisture or Humidity Problem | 2 | Device |
| 2021 | Incorrect, Inadequate or Imprecise Result or Readings | 6 | Device |
| 2021 | Inappropriate or Unexpected Reset | 3 | Device |
| 2021 | Display or Visual Feedback Problem | 41 | Device |
| 2021 | Communication or Transmission Problem | 436 | Device |
| 2021 | Calibration Problem | 12 | Device |
| 2021 | Break | 16 | Device |
| 2021 | Battery Problem | 65 | Device |
| 2021 | Appropriate Term/Code Not Available | 14 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2020 | Wireless Communication Problem | 4 | Device |
| 2020 | Communication or Transmission Problem | 2 | Device |