SENSOR, GLUCOSE, INVASIVE
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 | 2 | Patient |
| 2024 | Hyperglycemia | 3 | Patient |
| 2024 | Use of Device Problem | 9 | Device |
| 2024 | Unexpected Therapeutic Results | 6 | Device |
| 2024 | Packaging Problem | 3 | Device |
| 2024 | Incorrect, Inadequate or Imprecise Result or Readings | 6 | Device |
| 2024 | Fracture | 3 | Device |
| 2024 | Difficult to Remove | 2 | Device |
| 2024 | Delivered as Unsterile Product | 3 | Device |
| 2024 | Communication or Transmission Problem | 1 | Device |
| 2024 | Calibration Problem | 2 | Device |
| 2024 | Break | 2 | Device |
| 2024 | Appropriate Term/Code Not Available | 1 | Device |
| 2023 | Unspecified Infection | 1 | Patient |
| 2023 | Scar Tissue | 1 | Patient |
| 2023 | Hypoglycemia | 4 | Patient |
| 2023 | Hyperglycemia | 8 | Patient |
| 2023 | Wireless Communication Problem | 2 | Device |
| 2023 | Use of Device Problem | 56 | Device |
| 2023 | Unexpected Therapeutic Results | 26 | Device |
| 2023 | Physical Resistance/Sticking | 13 | Device |
| 2023 | Packaging Problem | 2 | Device |
| 2023 | Material Twisted/Bent | 3 | Device |
| 2023 | Manufacturing, Packaging or Shipping Problem | 2 | Device |
| 2023 | Incorrect, Inadequate or Imprecise Result or Readings | 8 | Device |
| 2023 | Fracture | 6 | Device |
| 2023 | Difficult to Remove | 1 | Device |
| 2023 | Communication or Transmission Problem | 3 | Device |
| 2023 | Calibration Problem | 21 | Device |
| 2023 | Break | 7 | Device |
| 2023 | Appropriate Term/Code Not Available | 11 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2022 | Vomiting | 1 | Patient |
| 2022 | Polydipsia | 3 | Patient |
| 2022 | Nausea | 2 | Patient |
| 2022 | Itching Sensation | 1 | Patient |
| 2022 | Hypoglycemia | 24 | Patient |
| 2022 | Hyperglycemia | 38 | Patient |
| 2022 | Dizziness | 1 | Patient |
| 2022 | Bone Fracture(s) | 1 | Patient |
| 2022 | Wireless Communication Problem | 79 | Device |
| 2022 | Use of Device Problem | 2 | Device |
| 2022 | Unexpected Therapeutic Results | 39 | Device |
| 2022 | Physical Resistance/Sticking | 411 | Device |
| 2022 | Patient Device Interaction Problem | 4 | Device |
| 2022 | Packaging Problem | 3 | Device |
| 2022 | No Apparent Adverse Event | 4 | Device |
| 2022 | Material Twisted/Bent | 7 | Device |
| 2022 | Manufacturing, Packaging or Shipping Problem | 2 | Device |
| 2022 | Incorrect, Inadequate or Imprecise Result or Readings | 22 | Device |
| 2022 | Fracture | 8 | Device |
| 2022 | Difficult to Remove | 1 | Device |
| 2022 | Communication or Transmission Problem | 54 | Device |
| 2022 | Calibration Problem | 61 | Device |
| 2022 | Break | 8 | Device |
| 2022 | Appropriate Term/Code Not Available | 11 | Device |
| 2022 | Activation Problem | 3 | Device |
| 2021 | Physical Resistance/Sticking | 4 | Device |
| 2021 | Appropriate Term/Code Not Available | 1 | Device |