INSET II 60/9 GREY TCAP
This device is manufactured by UNOMEDICAL A/S.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Infection | 8 | Patient |
| 2024 | Hypoglycemia | 24 | Patient |
| 2024 | Hyperglycemia | 776 | Patient |
| 2024 | Hemorrhage/Blood Loss/Bleeding | 9 | Patient |
| 2024 | Elevated ketones/Diabetic Ketoacidosis | 89 | Patient |
| 2024 | Coma | 1 | Patient |
| 2024 | Appropriate Term / Code Not Available | 2 | Patient |
| 2024 | No Apparent Adverse Event | 11 | Device |
| 2024 | Material Twisted/Bent | 722 | Device |
| 2024 | Material Split, Cut or Torn | 1 | Device |
| 2024 | Material Deformation | 29 | Device |
| 2024 | Loss of or Failure to Bond | 433 | Device |
| 2024 | Leak/Splash | 176 | Device |
| 2024 | Infusion or Flow Problem | 88 | Device |
| 2024 | Device Handling Problem | 12 | Device |
| 2024 | Detachment of Device or Device Component | 9 | Device |
| 2023 | Hyperglycemia | 13 | Patient |
| 2023 | Elevated ketones/Diabetic Ketoacidosis | 10 | Patient |
| 2023 | No Apparent Adverse Event | 1 | Device |
| 2023 | Material Twisted/Bent | 27 | Device |
| 2023 | Loss of or Failure to Bond | 9 | Device |
| 2023 | Leak/Splash | 1 | Device |
| 2023 | Infusion or Flow Problem | 3 | Device |
| 2023 | Detachment of Device or Device Component | 3 | Device |
| 2022 | Material Twisted/Bent | 11 | Device |
| 2022 | Material Deformation | 1 | Device |
| 2022 | Loss of or Failure to Bond | 1 | Device |
| 2022 | Detachment of Device or Device Component | 66 | Device |
| 2021 | Hyperglycemia | 12 | Patient |
| 2021 | Leak/Splash | 12 | Device |