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 | Vomiting | 2 | Patient |
| 2024 | Shaking/Tremors | 1 | Patient |
| 2024 | Nausea | 2 | Patient |
| 2024 | Malaise | 1 | Patient |
| 2024 | Macular Edema | 1 | Patient |
| 2024 | Hypoglycemia | 4 | Patient |
| 2024 | Hyperglycemia | 46 | Patient |
| 2024 | Fatigue | 1 | Patient |
| 2024 | Elevated ketones/Diabetic Ketoacidosis | 3 | Patient |
| 2024 | Dizziness | 1 | Patient |
| 2024 | Blurred Vision | 1 | Patient |
| 2024 | Abdominal Pain | 1 | Patient |
| 2024 | Visual Prompts will not Clear | 8 | Device |
| 2024 | Unintended Movement | 2 | Device |
| 2024 | Power Problem | 121 | Device |
| 2024 | Patient Device Interaction Problem | 2 | Device |
| 2024 | Obstruction of Flow | 59 | Device |
| 2024 | No Display/Image | 30 | Device |
| 2024 | Moisture or Humidity Problem | 14 | Device |
| 2024 | Mechanical Problem | 16 | Device |
| 2024 | Mechanical Jam | 1 | Device |
| 2024 | Material Integrity Problem | 23 | Device |
| 2024 | Key or Button Unresponsive/not Working | 24 | Device |
| 2024 | Intermittent Loss of Power | 1 | Device |
| 2024 | Insufficient Information | 11 | Device |
| 2024 | Insufficient Flow or Under Infusion | 7 | Device |
| 2024 | Human-Device Interface Problem | 1 | Device |
| 2024 | Failure of Device to Self-Test | 1 | Device |
| 2024 | Excess Flow or Over-Infusion | 1 | Device |
| 2024 | Electrical /Electronic Property Problem | 1 | Device |
| 2024 | Display or Visual Feedback Problem | 6 | Device |
| 2024 | Device Alarm System | 2 | Device |
| 2024 | Connection Problem | 1 | Device |
| 2024 | Computer Software Problem | 11 | Device |
| 2024 | Communication or Transmission Problem | 8 | Device |
| 2024 | Circuit Failure | 12 | Device |
| 2024 | Break | 40 | Device |
| 2024 | Battery Problem | 5 | Device |
| 2024 | Appropriate Term/Code Not Available | 32 | Device |
| 2024 | Application Program Problem: Dose Calculation Error | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 18 | Device |
| 2023 | Vomiting | 2 | Patient |
| 2023 | Shaking/Tremors | 2 | Patient |
| 2023 | Polydipsia | 1 | Patient |
| 2023 | Nausea | 3 | Patient |
| 2023 | Malaise | 2 | Patient |
| 2023 | Hypoglycemia | 16 | Patient |
| 2023 | Hyperglycemia | 27 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2023 | Headache | 1 | Patient |
| 2023 | Fatigue | 2 | Patient |
| 2023 | Elevated ketones/Diabetic Ketoacidosis | 3 | Patient |
| 2023 | Dizziness | 3 | Patient |
| 2023 | Diaphoresis | 1 | Patient |
| 2023 | Confusion/ Disorientation | 1 | Patient |
| 2023 | Anxiety | 1 | Patient |
| 2023 | Wireless Communication Problem | 6 | Device |
| 2023 | Visual Prompts will not Clear | 12 | Device |
| 2023 | Use of Device Problem | 2 | Device |
| 2023 | Unintended Movement | 7 | Device |
| 2023 | Unexpected Therapeutic Results | 1 | Device |
| 2023 | Power Problem | 221 | Device |
| 2023 | Obstruction of Flow | 19 | Device |
| 2023 | No Display/Image | 46 | Device |
| 2023 | Moisture or Humidity Problem | 46 | Device |
| 2023 | Mechanical Problem | 29 | Device |
| 2023 | Mechanical Jam | 2 | Device |
| 2023 | Material Integrity Problem | 69 | Device |
| 2023 | Loss of Data | 1 | Device |
| 2023 | Key or Button Unresponsive/not Working | 4 | Device |
| 2023 | Intermittent Loss of Power | 1 | Device |
| 2023 | Intermittent Communication Failure | 1 | Device |
| 2023 | Insufficient Information | 18 | Device |
| 2023 | Insufficient Flow or Under Infusion | 7 | Device |
| 2023 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2023 | Human-Device Interface Problem | 1 | Device |
| 2023 | Excess Flow or Over-Infusion | 6 | Device |
| 2023 | Electrical /Electronic Property Problem | 7 | Device |
| 2023 | Display or Visual Feedback Problem | 5 | Device |
| 2023 | Device Difficult to Program or Calibrate | 27 | Device |
| 2023 | Device Alarm System | 3 | Device |
| 2023 | Date/Time-Related Software Problem | 1 | Device |
| 2023 | Connection Problem | 4 | Device |
| 2023 | Computer Software Problem | 32 | Device |
| 2023 | Communication or Transmission Problem | 15 | Device |
| 2023 | Circuit Failure | 22 | Device |
| 2023 | Break | 78 | Device |
| 2023 | Battery Problem | 19 | Device |
| 2023 | Appropriate Term/Code Not Available | 31 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 22 | Device |
| 2022 | Loss of consciousness | 1 | Patient |
| 2022 | Hypoglycemia | 1 | Patient |
| 2022 | Hyperglycemia | 2 | Patient |
| 2022 | Elevated ketones/Diabetic Ketoacidosis | 1 | Patient |
| 2022 | Wireless Communication Problem | 11 | Device |
| 2022 | Visual Prompts will not Clear | 7 | Device |
| 2022 | Use of Device Problem | 2 | Device |
| 2022 | Unintended Movement | 6 | Device |
| 2022 | Power Problem | 294 | Device |
| 2022 | Patient Device Interaction Problem | 1 | Device |
| 2022 | Overheating of Device | 1 | Device |
| 2022 | Obstruction of Flow | 28 | Device |
| 2022 | No Display/Image | 41 | Device |
| 2022 | No Audible Prompt/Feedback | 1 | Device |
| 2022 | No Apparent Adverse Event | 7 | Device |
| 2022 | Moisture or Humidity Problem | 37 | Device |
| 2022 | Mechanical Problem | 36 | Device |
| 2022 | Mechanical Jam | 3 | Device |
| 2022 | Material Integrity Problem | 240 | Device |
| 2022 | Manufacturing, Packaging or Shipping Problem | 2 | Device |
| 2022 | Loss of Data | 1 | Device |
| 2022 | Intermittent Loss of Power | 1 | Device |
| 2022 | Intermittent Continuity | 1 | Device |
| 2022 | Insufficient Information | 2 | Device |
| 2022 | Insufficient Flow or Under Infusion | 8 | Device |
| 2022 | Human-Device Interface Problem | 1 | Device |
| 2022 | Failure of Device to Self-Test | 6 | Device |
| 2022 | Excess Flow or Over-Infusion | 6 | Device |
| 2022 | Environmental Compatibility Problem | 2 | Device |
| 2022 | Electrical /Electronic Property Problem | 3 | Device |
| 2022 | Display or Visual Feedback Problem | 7 | Device |
| 2022 | Device Markings/Labelling Problem | 1 | Device |
| 2022 | Device Difficult to Program or Calibrate | 38 | Device |
| 2022 | Device Alarm System | 4 | Device |
| 2022 | Date/Time-Related Software Problem | 2 | Device |
| 2022 | Crack | 1 | Device |
| 2022 | Connection Problem | 8 | Device |
| 2022 | Computer Software Problem | 46 | Device |
| 2022 | Communication or Transmission Problem | 29 | Device |
| 2022 | Circuit Failure | 17 | Device |
| 2022 | Break | 149 | Device |
| 2022 | Battery Problem | 19 | Device |
| 2022 | Appropriate Term/Code Not Available | 18 | Device |
| 2022 | Application Program Problem: Dose Calculation Error | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 32 | Device |
| 2021 | Wireless Communication Problem | 1 | Device |
| 2021 | Unintended Movement | 12 | Device |
| 2021 | Priming Problem | 1 | Device |
| 2021 | Power Problem | 51 | Device |
| 2021 | Patient Device Interaction Problem | 1 | Device |
| 2021 | Overheating of Device | 1 | Device |
| 2021 | Obstruction of Flow | 15 | Device |
| 2021 | No Display/Image | 12 | Device |
| 2021 | No Apparent Adverse Event | 3 | Device |
| 2021 | Moisture or Humidity Problem | 4 | Device |
| 2021 | Mechanical Problem | 1 | Device |
| 2021 | Material Integrity Problem | 161 | Device |
| 2021 | Loss of Data | 1 | Device |
| 2021 | Insufficient Flow or Under Infusion | 1 | Device |
| 2021 | Environmental Compatibility Problem | 3 | Device |
| 2021 | Electrical /Electronic Property Problem | 2 | Device |
| 2021 | Device Markings/Labelling Problem | 1 | Device |
| 2021 | Device Difficult to Program or Calibrate | 2 | Device |
| 2021 | Device Alarm System | 1 | Device |
| 2021 | Connection Problem | 5 | Device |
| 2021 | Computer Software Problem | 15 | Device |
| 2021 | Communication or Transmission Problem | 8 | Device |
| 2021 | Circuit Failure | 7 | Device |
| 2021 | Break | 125 | Device |
| 2021 | Battery Problem | 3 | Device |
| 2021 | Appropriate Term/Code Not Available | 2 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2020 | Power Problem | 1 | Device |
| 2020 | Overheating of Device | 1 | Device |
| 2020 | No Display/Image | 1 | Device |
| 2020 | Moisture or Humidity Problem | 1 | Device |
| 2020 | Break | 2 | Device |