ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL
This device is manufactured by MEDTRONIC MINIMED, MEDTRONIC PUERTO RICO OPERATIONS CO.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Hypoglycemia | 7 | Patient |
| 2024 | Hyperglycemia | 4 | Patient |
| 2024 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2024 | Use of Device Problem | 3 | Device |
| 2024 | Unexpected Therapeutic Results | 10 | Device |
| 2024 | Incorrect, Inadequate or Imprecise Result or Readings | 15 | Device |
| 2024 | Fracture | 2 | Device |
| 2024 | Difficult to Remove | 2 | Device |
| 2024 | Calibration Problem | 5 | Device |
| 2024 | Break | 1 | Device |
| 2023 | Unspecified Infection | 1 | Patient |
| 2023 | Swelling/ Edema | 1 | Patient |
| 2023 | Skin Inflammation/ Irritation | 1 | Patient |
| 2023 | Skin Erosion | 1 | Patient |
| 2023 | Purulent Discharge | 1 | Patient |
| 2023 | Itching Sensation | 1 | Patient |
| 2023 | Hypoglycemia | 6 | Patient |
| 2023 | Hyperglycemia | 3 | Patient |
| 2023 | Wireless Communication Problem | 2 | Device |
| 2023 | Use of Device Problem | 28 | Device |
| 2023 | Unexpected Therapeutic Results | 17 | Device |
| 2023 | Physical Resistance/Sticking | 3 | Device |
| 2023 | Packaging Problem | 2 | Device |
| 2023 | Material Twisted/Bent | 2 | Device |
| 2023 | Incorrect, Inadequate or Imprecise Result or Readings | 2 | Device |
| 2023 | Fracture | 2 | Device |
| 2023 | Delivered as Unsterile Product | 1 | Device |
| 2023 | Communication or Transmission Problem | 2 | Device |
| 2023 | Calibration Problem | 9 | Device |
| 2023 | Break | 2 | Device |
| 2023 | Appropriate Term/Code Not Available | 2 | Device |
| 2023 | Activation Problem | 1 | Device |
| 2022 | Shaking/Tremors | 2 | Patient |
| 2022 | Pain | 2 | Patient |
| 2022 | Hypoglycemia | 27 | Patient |
| 2022 | Hyperglycemia | 53 | Patient |
| 2022 | Confusion/ Disorientation | 1 | Patient |
| 2022 | Anxiety | 1 | Patient |
| 2022 | Wireless Communication Problem | 131 | Device |
| 2022 | Use of Device Problem | 4 | Device |
| 2022 | Unexpected Therapeutic Results | 39 | Device |
| 2022 | Physical Resistance/Sticking | 519 | Device |
| 2022 | Patient Device Interaction Problem | 1 | Device |
| 2022 | Packaging Problem | 6 | Device |
| 2022 | Obstruction of Flow | 1 | Device |
| 2022 | No Apparent Adverse Event | 2 | Device |
| 2022 | Material Twisted/Bent | 4 | Device |
| 2022 | Manufacturing, Packaging or Shipping Problem | 1 | Device |
| 2022 | Incorrect, Inadequate or Imprecise Result or Readings | 13 | Device |
| 2022 | Fracture | 1 | Device |
| 2022 | Communication or Transmission Problem | 101 | Device |
| 2022 | Calibration Problem | 65 | Device |
| 2022 | Break | 8 | Device |
| 2022 | Appropriate Term/Code Not Available | 12 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2022 | Activation Problem | 3 | Device |
| 2021 | Hyperglycemia | 1 | Patient |
| 2021 | Wireless Communication Problem | 1 | Device |
| 2021 | Physical Resistance/Sticking | 4 | Device |
| 2021 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2021 | Communication or Transmission Problem | 1 | Device |
| 2021 | Calibration Problem | 1 | Device |
| 2021 | Break | 1 | Device |