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 | 1 | Patient |
| 2024 | Polydipsia | 1 | Patient |
| 2024 | Myocardial Contusion | 1 | Patient |
| 2024 | Hypoglycemia | 4 | Patient |
| 2024 | Hyperglycemia | 27 | Patient |
| 2024 | Fatigue | 1 | Patient |
| 2024 | Elevated ketones/Diabetic Ketoacidosis | 1 | Patient |
| 2024 | Dehydration | 1 | Patient |
| 2024 | Convulsion, Clonic | 1 | Patient |
| 2024 | Visual Prompts will not Clear | 7 | Device |
| 2024 | Unintended Movement | 4 | Device |
| 2024 | Priming Problem | 2 | Device |
| 2024 | Power Problem | 81 | Device |
| 2024 | Patient Device Interaction Problem | 1 | Device |
| 2024 | Obstruction of Flow | 20 | Device |
| 2024 | No Display/Image | 15 | Device |
| 2024 | Moisture or Humidity Problem | 7 | Device |
| 2024 | Mechanical Problem | 13 | Device |
| 2024 | Mechanical Jam | 4 | Device |
| 2024 | Material Integrity Problem | 12 | Device |
| 2024 | Manufacturing, Packaging or Shipping Problem | 1 | Device |
| 2024 | Loss of Data | 2 | Device |
| 2024 | Key or Button Unresponsive/not Working | 23 | Device |
| 2024 | Insufficient Information | 6 | Device |
| 2024 | Insufficient Flow or Under Infusion | 1 | Device |
| 2024 | Excess Flow or Over-Infusion | 2 | Device |
| 2024 | Environmental Compatibility Problem | 2 | Device |
| 2024 | Electrical /Electronic Property Problem | 1 | Device |
| 2024 | Display or Visual Feedback Problem | 7 | Device |
| 2024 | Date/Time-Related Software Problem | 1 | Device |
| 2024 | Connection Problem | 3 | Device |
| 2024 | Computer Software Problem | 1 | Device |
| 2024 | Communication or Transmission Problem | 3 | Device |
| 2024 | Circuit Failure | 7 | Device |
| 2024 | Break | 61 | Device |
| 2024 | Battery Problem | 5 | Device |
| 2024 | Appropriate Term/Code Not Available | 19 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 12 | Device |
| 2023 | Vomiting | 4 | Patient |
| 2023 | Viral Infection | 1 | Patient |
| 2023 | Urinary Frequency | 1 | Patient |
| 2023 | Syncope/Fainting | 1 | Patient |
| 2023 | Shaking/Tremors | 2 | Patient |
| 2023 | Polydipsia | 2 | Patient |
| 2023 | Nausea | 1 | Patient |
| 2023 | Malaise | 1 | Patient |
| 2023 | Hypoglycemia | 19 | Patient |
| 2023 | Hyperglycemia | 62 | Patient |
| 2023 | High Blood Pressure/ Hypertension | 1 | Patient |
| 2023 | Fatigue | 1 | Patient |
| 2023 | Extreme Exhaustion | 1 | Patient |
| 2023 | Elevated ketones/Diabetic Ketoacidosis | 6 | Patient |
| 2023 | Diarrhea | 1 | Patient |
| 2023 | Convulsion, Clonic | 1 | Patient |
| 2023 | Confusion/ Disorientation | 1 | Patient |
| 2023 | Coma | 1 | Patient |
| 2023 | Chest Pain | 1 | Patient |
| 2023 | Bone Cement Implantation Syndrome | 1 | Patient |
| 2023 | Abdominal Pain | 1 | Patient |
| 2023 | Wireless Communication Problem | 1 | Device |
| 2023 | Visual Prompts will not Clear | 10 | Device |
| 2023 | Use of Device Problem | 1 | Device |
| 2023 | Unintended Movement | 4 | Device |
| 2023 | Priming Problem | 4 | Device |
| 2023 | Power Problem | 189 | Device |
| 2023 | Overheating of Device | 1 | Device |
| 2023 | Obstruction of Flow | 42 | Device |
| 2023 | No Display/Image | 47 | Device |
| 2023 | Moisture or Humidity Problem | 34 | Device |
| 2023 | Mechanical Problem | 29 | Device |
| 2023 | Mechanical Jam | 3 | Device |
| 2023 | Material Integrity Problem | 63 | Device |
| 2023 | Manufacturing, Packaging or Shipping Problem | 3 | Device |
| 2023 | Loss of Data | 4 | 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 | 28 | Device |
| 2023 | Insufficient Flow or Under Infusion | 13 | Device |
| 2023 | Failure of Device to Self-Test | 1 | Device |
| 2023 | Excess Flow or Over-Infusion | 3 | Device |
| 2023 | Environmental Compatibility Problem | 3 | Device |
| 2023 | Electrical /Electronic Property Problem | 5 | Device |
| 2023 | Display or Visual Feedback Problem | 16 | Device |
| 2023 | Device Difficult to Program or Calibrate | 41 | Device |
| 2023 | Device Alarm System | 6 | Device |
| 2023 | Date/Time-Related Software Problem | 1 | Device |
| 2023 | Connection Problem | 10 | Device |
| 2023 | Computer Software Problem | 9 | Device |
| 2023 | Communication or Transmission Problem | 6 | Device |
| 2023 | Circuit Failure | 11 | Device |
| 2023 | Break | 140 | Device |
| 2023 | Battery Problem | 10 | Device |
| 2023 | Appropriate Term/Code Not Available | 41 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 31 | Device |
| 2022 | Vomiting | 1 | Patient |
| 2022 | Tachycardia | 1 | Patient |
| 2022 | Polydipsia | 1 | Patient |
| 2022 | Nausea | 1 | Patient |
| 2022 | Loss of consciousness | 1 | Patient |
| 2022 | Hypoglycemia | 6 | Patient |
| 2022 | Hyperglycemia | 7 | Patient |
| 2022 | Dizziness | 1 | Patient |
| 2022 | Convulsion, Clonic | 1 | Patient |
| 2022 | Wireless Communication Problem | 15 | Device |
| 2022 | Visual Prompts will not Clear | 6 | Device |
| 2022 | Use of Device Problem | 4 | Device |
| 2022 | Unintended Movement | 6 | Device |
| 2022 | Unauthorized Access to Computer System | 1 | Device |
| 2022 | Priming Problem | 1 | Device |
| 2022 | Power Problem | 298 | Device |
| 2022 | Patient Device Interaction Problem | 1 | Device |
| 2022 | Overheating of Device | 1 | Device |
| 2022 | Obstruction of Flow | 27 | Device |
| 2022 | No Display/Image | 66 | Device |
| 2022 | No Apparent Adverse Event | 8 | Device |
| 2022 | Moisture or Humidity Problem | 65 | Device |
| 2022 | Mechanical Problem | 49 | Device |
| 2022 | Mechanical Jam | 3 | Device |
| 2022 | Material Integrity Problem | 202 | Device |
| 2022 | Loss of Data | 9 | Device |
| 2022 | Intermittent Loss of Power | 3 | Device |
| 2022 | Intermittent Communication Failure | 1 | Device |
| 2022 | Insufficient Information | 5 | Device |
| 2022 | Insufficient Flow or Under Infusion | 17 | Device |
| 2022 | Failure of Device to Self-Test | 2 | Device |
| 2022 | Excess Flow or Over-Infusion | 9 | Device |
| 2022 | Environmental Compatibility Problem | 1 | Device |
| 2022 | Electrical /Electronic Property Problem | 6 | Device |
| 2022 | Display or Visual Feedback Problem | 5 | Device |
| 2022 | Device Markings/Labelling Problem | 1 | Device |
| 2022 | Device Difficult to Program or Calibrate | 37 | Device |
| 2022 | Device Alarm System | 7 | Device |
| 2022 | Connection Problem | 26 | Device |
| 2022 | Computer Software Problem | 58 | Device |
| 2022 | Communication or Transmission Problem | 41 | Device |
| 2022 | Circuit Failure | 28 | Device |
| 2022 | Break | 298 | Device |
| 2022 | Battery Problem | 26 | Device |
| 2022 | Appropriate Term/Code Not Available | 35 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 58 | Device |
| 2021 | Wireless Communication Problem | 6 | Device |
| 2021 | Visual Prompts will not Clear | 3 | Device |
| 2021 | Use of Device Problem | 1 | Device |
| 2021 | Unintended Movement | 12 | Device |
| 2021 | Power Problem | 43 | Device |
| 2021 | Patient Device Interaction Problem | 7 | Device |
| 2021 | Overheating of Device | 2 | Device |
| 2021 | Obstruction of Flow | 14 | Device |
| 2021 | No Display/Image | 52 | Device |
| 2021 | No Apparent Adverse Event | 11 | Device |
| 2021 | Moisture or Humidity Problem | 4 | Device |
| 2021 | Mechanical Problem | 8 | Device |
| 2021 | Mechanical Jam | 2 | Device |
| 2021 | Material Integrity Problem | 181 | Device |
| 2021 | Loss of Data | 4 | Device |
| 2021 | Intermittent Loss of Power | 2 | Device |
| 2021 | Intermittent Communication Failure | 1 | Device |
| 2021 | Insufficient Information | 3 | Device |
| 2021 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2021 | Electrical /Electronic Property Problem | 4 | Device |
| 2021 | Display or Visual Feedback Problem | 4 | Device |
| 2021 | Device Markings/Labelling Problem | 1 | Device |
| 2021 | Device Difficult to Program or Calibrate | 1 | Device |
| 2021 | Device Alarm System | 1 | Device |
| 2021 | Connection Problem | 7 | Device |
| 2021 | Computer Software Problem | 20 | Device |
| 2021 | Communication or Transmission Problem | 14 | Device |
| 2021 | Circuit Failure | 8 | Device |
| 2021 | Break | 241 | Device |
| 2021 | Battery Problem | 12 | Device |
| 2021 | Appropriate Term/Code Not Available | 9 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2020 | Wireless Communication Problem | 1 | Device |
| 2020 | Unexpected Therapeutic Results | 1 | Device |
| 2020 | Power Problem | 5 | Device |
| 2020 | Patient Device Interaction Problem | 49 | Device |
| 2020 | Obstruction of Flow | 3 | Device |
| 2020 | Nonstandard Device | 2 | Device |
| 2020 | Moisture or Humidity Problem | 2 | Device |
| 2020 | Mechanical Problem | 1 | Device |
| 2020 | Mechanical Jam | 1 | Device |
| 2020 | Intermittent Loss of Power | 1 | Device |
| 2020 | Insufficient Information | 1 | Device |
| 2020 | Device Markings/Labelling Problem | 1 | Device |
| 2020 | Device Alarm System | 1 | Device |
| 2020 | Communication or Transmission Problem | 3 | Device |
| 2020 | Circuit Failure | 2 | Device |
| 2020 | Break | 103 | Device |
| 2020 | Battery Problem | 2 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 1 | Device |