ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
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 | Visual Impairment | 1 | Patient |
| 2024 | Hypoglycemia | 3 | Patient |
| 2024 | Hyperglycemia | 12 | Patient |
| 2024 | Elevated ketones/Diabetic Ketoacidosis | 1 | Patient |
| 2024 | Visual Prompts will not Clear | 1 | Device |
| 2024 | Priming Problem | 2 | Device |
| 2024 | Power Problem | 20 | Device |
| 2024 | Obstruction of Flow | 11 | Device |
| 2024 | No Display/Image | 9 | Device |
| 2024 | Moisture or Humidity Problem | 3 | Device |
| 2024 | Mechanical Problem | 5 | Device |
| 2024 | Material Integrity Problem | 3 | Device |
| 2024 | Key or Button Unresponsive/not Working | 6 | Device |
| 2024 | Insufficient Information | 2 | Device |
| 2024 | Insufficient Flow or Under Infusion | 2 | Device |
| 2024 | Display or Visual Feedback Problem | 2 | Device |
| 2024 | Date/Time-Related Software Problem | 1 | Device |
| 2024 | Break | 16 | Device |
| 2024 | Battery Problem | 4 | Device |
| 2024 | Appropriate Term/Code Not Available | 11 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2023 | Respiratory Failure | 1 | Patient |
| 2023 | Pain | 1 | Patient |
| 2023 | Insufficient Information | 5 | Patient |
| 2023 | Hypoglycemia | 3 | Patient |
| 2023 | Hyperglycemia | 14 | Patient |
| 2023 | Headache | 1 | Patient |
| 2023 | Elevated ketones/Diabetic Ketoacidosis | 2 | Patient |
| 2023 | Confusion/ Disorientation | 1 | Patient |
| 2023 | Abdominal Cramps | 1 | Patient |
| 2023 | Power Problem | 36 | Device |
| 2023 | Obstruction of Flow | 9 | Device |
| 2023 | No Display/Image | 17 | Device |
| 2023 | Moisture or Humidity Problem | 4 | Device |
| 2023 | Mechanical Problem | 2 | Device |
| 2023 | Mechanical Jam | 1 | Device |
| 2023 | Material Integrity Problem | 10 | Device |
| 2023 | Key or Button Unresponsive/not Working | 1 | Device |
| 2023 | Insufficient Information | 1 | Device |
| 2023 | Insufficient Flow or Under Infusion | 3 | Device |
| 2023 | Electrical /Electronic Property Problem | 1 | Device |
| 2023 | Display or Visual Feedback Problem | 1 | Device |
| 2023 | Device Difficult to Program or Calibrate | 5 | Device |
| 2023 | Device Alarm System | 2 | Device |
| 2023 | Connection Problem | 2 | Device |
| 2023 | Break | 43 | Device |
| 2023 | Battery Problem | 1 | Device |
| 2023 | Appropriate Term/Code Not Available | 24 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2022 | Malaise | 1 | Patient |
| 2022 | Loss of consciousness | 1 | Patient |
| 2022 | Insufficient Information | 1 | Patient |
| 2022 | Hypoglycemia | 4 | Patient |
| 2022 | Hyperglycemia | 2 | Patient |
| 2022 | Headache | 1 | Patient |
| 2022 | Fatigue | 1 | Patient |
| 2022 | Elevated ketones/Diabetic Ketoacidosis | 1 | Patient |
| 2022 | Dizziness | 1 | Patient |
| 2022 | Confusion/ Disorientation | 1 | Patient |
| 2022 | Appropriate Term / Code Not Available | 2 | Patient |
| 2022 | Wireless Communication Problem | 1 | Device |
| 2022 | Visual Prompts will not Clear | 1 | Device |
| 2022 | Priming Problem | 3 | Device |
| 2022 | Power Problem | 51 | Device |
| 2022 | Obstruction of Flow | 13 | Device |
| 2022 | No Display/Image | 30 | Device |
| 2022 | No Apparent Adverse Event | 1 | Device |
| 2022 | Moisture or Humidity Problem | 1 | Device |
| 2022 | Mechanical Problem | 5 | Device |
| 2022 | Mechanical Jam | 1 | Device |
| 2022 | Material Integrity Problem | 17 | Device |
| 2022 | Insufficient Flow or Under Infusion | 4 | Device |
| 2022 | Excess Flow or Over-Infusion | 1 | Device |
| 2022 | Electrical /Electronic Property Problem | 1 | Device |
| 2022 | Display or Visual Feedback Problem | 2 | Device |
| 2022 | Device Markings/Labelling Problem | 1 | Device |
| 2022 | Device Difficult to Program or Calibrate | 3 | Device |
| 2022 | Device Alarm System | 3 | Device |
| 2022 | Connection Problem | 3 | Device |
| 2022 | Computer Software Problem | 1 | Device |
| 2022 | Break | 43 | Device |
| 2022 | Battery Problem | 6 | Device |
| 2022 | Appropriate Term/Code Not Available | 9 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 21 | Device |
| 2021 | Loss of consciousness | 1 | Patient |
| 2021 | Insufficient Information | 3 | Patient |
| 2021 | Fatigue | 1 | Patient |
| 2021 | Elevated ketones/Diabetic Ketoacidosis | 1 | Patient |
| 2021 | Unintended Movement | 1 | Device |
| 2021 | Power Problem | 9 | Device |
| 2021 | Patient Device Interaction Problem | 1 | Device |
| 2021 | Obstruction of Flow | 8 | Device |
| 2021 | No Display/Image | 30 | Device |
| 2021 | No Apparent Adverse Event | 2 | Device |
| 2021 | Mechanical Problem | 1 | Device |
| 2021 | Material Integrity Problem | 32 | Device |
| 2021 | Insufficient Flow or Under Infusion | 2 | Device |
| 2021 | Excess Flow or Over-Infusion | 1 | Device |
| 2021 | Electrical /Electronic Property Problem | 1 | Device |
| 2021 | Device Markings/Labelling Problem | 1 | Device |
| 2021 | Device Difficult to Program or Calibrate | 1 | Device |
| 2021 | Date/Time-Related Software Problem | 1 | Device |
| 2021 | Break | 32 | Device |
| 2021 | Battery Problem | 4 | Device |
| 2021 | Appropriate Term/Code Not Available | 4 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2020 | Hyperglycemia | 1 | Patient |
| 2020 | Power Problem | 1 | Device |
| 2020 | Patient Device Interaction Problem | 1 | Device |
| 2020 | Break | 7 | Device |
| 2020 | Battery Problem | 1 | Device |
| 2020 | Appropriate Term/Code Not Available | 1 | Device |
| 2019 | Vomiting | 1 | Patient |
| 2019 | Urinary Tract Infection | 2 | Patient |
| 2019 | Pain | 1 | Patient |
| 2019 | Nausea | 2 | Patient |
| 2019 | Insufficient Information | 3 | Patient |
| 2019 | Hyperglycemia | 2 | Patient |
| 2019 | Elevated ketones/Diabetic Ketoacidosis | 1 | Patient |
| 2019 | Dyspnea | 1 | Patient |
| 2019 | Diarrhea | 1 | Patient |
| 2019 | Chest Pain | 1 | Patient |
| 2019 | Appropriate Term / Code Not Available | 1 | Patient |
| 2019 | Abdominal Pain | 1 | Patient |
| 2019 | Visual Prompts will not Clear | 3 | Device |
| 2019 | Unintended Movement | 1 | Device |
| 2019 | Priming Problem | 2 | Device |
| 2019 | Power Problem | 21 | Device |
| 2019 | Patient Device Interaction Problem | 18 | Device |
| 2019 | Obstruction of Flow | 24 | Device |
| 2019 | No Display/Image | 36 | Device |
| 2019 | No Apparent Adverse Event | 119 | Device |
| 2019 | Moisture or Humidity Problem | 4 | Device |
| 2019 | Mechanical Problem | 20 | Device |
| 2019 | Mechanical Jam | 3 | Device |
| 2019 | Material Integrity Problem | 1 | Device |
| 2019 | Intermittent Loss of Power | 1 | Device |
| 2019 | Insufficient Information | 2 | Device |
| 2019 | Insufficient Flow or Under Infusion | 17 | Device |
| 2019 | Failure of Device to Self-Test | 1 | Device |
| 2019 | Excess Flow or Over-Infusion | 3 | Device |
| 2019 | Electrical /Electronic Property Problem | 3 | Device |
| 2019 | Display or Visual Feedback Problem | 13 | Device |
| 2019 | Device Markings/Labelling Problem | 1 | Device |
| 2019 | Device Difficult to Program or Calibrate | 14 | Device |
| 2019 | Device Alarm System | 10 | Device |
| 2019 | Connection Problem | 3 | Device |
| 2019 | Computer Software Problem | 1 | Device |
| 2019 | Break | 5 | Device |
| 2019 | Battery Problem | 2 | Device |
| 2019 | Appropriate Term/Code Not Available | 30 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 177 | Device |
| 2018 | Insufficient Information | 1 | Patient |
| 2018 | Break | 1 | Device |
| 2018 | Appropriate Term/Code Not Available | 1 | Device |
| 2017 | Insufficient Information | 1 | Patient |
| 2017 | Break | 2 | Device |
| 2017 | Appropriate Term/Code Not Available | 1 | Device |
| 2016 | Appropriate Term / Code Not Available | 3 | Patient |
| 2016 | Break | 4 | Device |
| 2016 | Appropriate Term/Code Not Available | 3 | Device |