ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL
This device is manufactured by MEDTRONIC PUERTO RICO OPERATIONS CO.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Hypoglycemia | 1 | Patient |
| 2024 | Hyperglycemia | 5 | Patient |
| 2024 | Visual Prompts will not Clear | 1 | Device |
| 2024 | Unintended Movement | 2 | Device |
| 2024 | Power Problem | 29 | Device |
| 2024 | Obstruction of Flow | 5 | Device |
| 2024 | No Display/Image | 4 | Device |
| 2024 | Moisture or Humidity Problem | 4 | Device |
| 2024 | Mechanical Problem | 7 | Device |
| 2024 | Material Integrity Problem | 10 | Device |
| 2024 | Key or Button Unresponsive/not Working | 10 | Device |
| 2024 | Intermittent Loss of Power | 1 | Device |
| 2024 | Insufficient Information | 1 | Device |
| 2024 | Electrical /Electronic Property Problem | 1 | Device |
| 2024 | Device Alarm System | 1 | Device |
| 2024 | Connection Problem | 1 | Device |
| 2024 | Computer Software Problem | 1 | Device |
| 2024 | Circuit Failure | 2 | Device |
| 2024 | Break | 28 | Device |
| 2024 | Battery Problem | 1 | Device |
| 2024 | Appropriate Term/Code Not Available | 4 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2023 | Vomiting | 1 | Patient |
| 2023 | Numbness | 1 | Patient |
| 2023 | Insufficient Information | 1 | Patient |
| 2023 | Hypoglycemia | 6 | Patient |
| 2023 | Hyperglycemia | 27 | Patient |
| 2023 | Elevated ketones/Diabetic Ketoacidosis | 2 | Patient |
| 2023 | Dysphasia | 1 | Patient |
| 2023 | Diaphoresis | 1 | Patient |
| 2023 | Cramp(s) /Muscle Spasm(s) | 1 | Patient |
| 2023 | Arrhythmia | 1 | Patient |
| 2023 | Appropriate Term / Code Not Available | 1 | Patient |
| 2023 | Wireless Communication Problem | 2 | Device |
| 2023 | Visual Prompts will not Clear | 5 | Device |
| 2023 | Unintended Movement | 1 | Device |
| 2023 | Priming Problem | 2 | Device |
| 2023 | Power Problem | 72 | Device |
| 2023 | Obstruction of Flow | 10 | Device |
| 2023 | No Display/Image | 26 | Device |
| 2023 | Moisture or Humidity Problem | 20 | Device |
| 2023 | Mechanical Problem | 19 | Device |
| 2023 | Mechanical Jam | 1 | Device |
| 2023 | Material Integrity Problem | 28 | Device |
| 2023 | Manufacturing, Packaging or Shipping Problem | 1 | Device |
| 2023 | Loss of Data | 2 | Device |
| 2023 | Insufficient Information | 24 | Device |
| 2023 | Insufficient Flow or Under Infusion | 5 | Device |
| 2023 | Human-Device Interface Problem | 1 | Device |
| 2023 | Failure of Device to Self-Test | 1 | Device |
| 2023 | Excess Flow or Over-Infusion | 4 | Device |
| 2023 | Electrical /Electronic Property Problem | 5 | Device |
| 2023 | Display or Visual Feedback Problem | 4 | Device |
| 2023 | Device Difficult to Program or Calibrate | 17 | Device |
| 2023 | Device Alarm System | 2 | Device |
| 2023 | Connection Problem | 2 | Device |
| 2023 | Computer Software Problem | 9 | Device |
| 2023 | Communication or Transmission Problem | 6 | Device |
| 2023 | Circuit Failure | 10 | Device |
| 2023 | Break | 66 | Device |
| 2023 | Battery Problem | 7 | Device |
| 2023 | Appropriate Term/Code Not Available | 15 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 15 | Device |
| 2022 | Urinary Retention | 1 | Patient |
| 2022 | Loss of consciousness | 1 | Patient |
| 2022 | Hypothermia | 1 | Patient |
| 2022 | Hypoglycemia | 1 | Patient |
| 2022 | Hyperglycemia | 4 | Patient |
| 2022 | Wireless Communication Problem | 13 | Device |
| 2022 | Visual Prompts will not Clear | 7 | Device |
| 2022 | Use of Device Problem | 2 | Device |
| 2022 | Unintended Movement | 4 | Device |
| 2022 | Unexpected Therapeutic Results | 1 | Device |
| 2022 | Power Problem | 146 | Device |
| 2022 | Overheating of Device | 2 | Device |
| 2022 | Obstruction of Flow | 24 | Device |
| 2022 | No Display/Image | 39 | Device |
| 2022 | No Apparent Adverse Event | 1 | Device |
| 2022 | Moisture or Humidity Problem | 31 | Device |
| 2022 | Mechanical Problem | 30 | Device |
| 2022 | Mechanical Jam | 3 | Device |
| 2022 | Material Integrity Problem | 89 | Device |
| 2022 | Manufacturing, Packaging or Shipping Problem | 1 | Device |
| 2022 | Loss of Data | 6 | Device |
| 2022 | Intermittent Loss of Power | 3 | Device |
| 2022 | Intermittent Communication Failure | 1 | Device |
| 2022 | Insufficient Information | 4 | Device |
| 2022 | Insufficient Flow or Under Infusion | 6 | Device |
| 2022 | Failure of Device to Self-Test | 2 | Device |
| 2022 | Excess Flow or Over-Infusion | 1 | Device |
| 2022 | Environmental Compatibility Problem | 2 | Device |
| 2022 | Electrical /Electronic Property Problem | 5 | Device |
| 2022 | Display or Visual Feedback Problem | 5 | Device |
| 2022 | Device Markings/Labelling Problem | 1 | Device |
| 2022 | Device Difficult to Program or Calibrate | 23 | Device |
| 2022 | Device Alarm System | 3 | Device |
| 2022 | Date/Time-Related Software Problem | 1 | Device |
| 2022 | Computer Software Problem | 30 | Device |
| 2022 | Communication or Transmission Problem | 25 | Device |
| 2022 | Circuit Failure | 10 | Device |
| 2022 | Break | 98 | Device |
| 2022 | Battery Problem | 20 | Device |
| 2022 | Appropriate Term/Code Not Available | 12 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 23 | Device |
| 2021 | Wireless Communication Problem | 1 | Device |
| 2021 | Unintended Movement | 3 | Device |
| 2021 | Power Problem | 12 | Device |
| 2021 | Obstruction of Flow | 2 | Device |
| 2021 | No Display/Image | 4 | Device |
| 2021 | Moisture or Humidity Problem | 1 | Device |
| 2021 | Mechanical Problem | 2 | Device |
| 2021 | Material Integrity Problem | 21 | Device |
| 2021 | Loss of Data | 1 | Device |
| 2021 | Intermittent Loss of Power | 1 | Device |
| 2021 | Failure to Align | 1 | Device |
| 2021 | Computer Software Problem | 9 | Device |
| 2021 | Communication or Transmission Problem | 3 | Device |
| 2021 | Break | 16 | Device |
| 2021 | Battery Problem | 4 | Device |
| 2021 | Appropriate Term/Code Not Available | 1 | Device |
| 2020 | Power Problem | 1 | Device |
| 2020 | Battery Problem | 1 | Device |