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 | Vomiting | 3 | Patient |
| 2024 | Unspecified Infection | 1 | Patient |
| 2024 | Stacking Breaths | 1 | Patient |
| 2024 | Shaking/Tremors | 1 | Patient |
| 2024 | Pain | 1 | Patient |
| 2024 | Nausea | 1 | Patient |
| 2024 | Muscle Weakness/Atrophy | 1 | Patient |
| 2024 | Malaise | 3 | Patient |
| 2024 | Loss of consciousness | 2 | Patient |
| 2024 | Insufficient Information | 1 | Patient |
| 2024 | Hypoglycemia | 34 | Patient |
| 2024 | Hyperglycemia | 98 | Patient |
| 2024 | Hemorrhage/Blood Loss/Bleeding | 2 | Patient |
| 2024 | Hematoma | 1 | Patient |
| 2024 | Heart Failure/Congestive Heart Failure | 1 | Patient |
| 2024 | Headache | 3 | Patient |
| 2024 | Fatigue | 2 | Patient |
| 2024 | Elevated ketones/Diabetic Ketoacidosis | 8 | Patient |
| 2024 | Dyspnea | 1 | Patient |
| 2024 | Diaphoresis | 1 | Patient |
| 2024 | Convulsion, Clonic | 1 | Patient |
| 2024 | Confusion/ Disorientation | 4 | Patient |
| 2024 | Bruise/Contusion | 2 | Patient |
| 2024 | Bone Cement Implantation Syndrome | 1 | Patient |
| 2024 | Anxiety | 1 | Patient |
| 2024 | Wireless Communication Problem | 6 | Device |
| 2024 | Visual Prompts will not Clear | 7 | Device |
| 2024 | Use of Device Problem | 4 | Device |
| 2024 | Priming Problem | 17 | Device |
| 2024 | Power Problem | 236 | Device |
| 2024 | Overheating of Device | 1 | Device |
| 2024 | Obstruction of Flow | 238 | Device |
| 2024 | No Display/Image | 86 | Device |
| 2024 | Moisture or Humidity Problem | 24 | Device |
| 2024 | Mechanical Problem | 67 | Device |
| 2024 | Mechanical Jam | 3 | Device |
| 2024 | Material Integrity Problem | 43 | Device |
| 2024 | Loss of Data | 2 | Device |
| 2024 | Key or Button Unresponsive/not Working | 81 | Device |
| 2024 | Insufficient Information | 19 | Device |
| 2024 | Insufficient Flow or Under Infusion | 26 | Device |
| 2024 | Human-Device Interface Problem | 1 | Device |
| 2024 | Failure of Device to Self-Test | 3 | Device |
| 2024 | Excess Flow or Over-Infusion | 9 | Device |
| 2024 | Electrical /Electronic Property Problem | 1 | Device |
| 2024 | Display or Visual Feedback Problem | 12 | Device |
| 2024 | Device Alarm System | 18 | Device |
| 2024 | Date/Time-Related Software Problem | 3 | Device |
| 2024 | Connection Problem | 5 | Device |
| 2024 | Computer Software Problem | 2 | Device |
| 2024 | Circuit Failure | 4 | Device |
| 2024 | Break | 150 | Device |
| 2024 | Battery Problem | 65 | Device |
| 2024 | Appropriate Term/Code Not Available | 117 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 47 | Device |
| 2023 | Vomiting | 10 | Patient |
| 2023 | Syncope/Fainting | 2 | Patient |
| 2023 | Sleep Dysfunction | 1 | Patient |
| 2023 | Shaking/Tremors | 5 | Patient |
| 2023 | Polydipsia | 5 | Patient |
| 2023 | Pneumonia | 2 | Patient |
| 2023 | Pain | 2 | Patient |
| 2023 | Nausea | 5 | Patient |
| 2023 | Myocardial Infarction | 1 | Patient |
| 2023 | Muscle Weakness/Atrophy | 1 | Patient |
| 2023 | Malaise | 9 | Patient |
| 2023 | Macular Edema | 2 | Patient |
| 2023 | Loss of consciousness | 4 | Patient |
| 2023 | Insufficient Information | 19 | Patient |
| 2023 | Hypoglycemia | 68 | Patient |
| 2023 | Hypervolemia | 1 | Patient |
| 2023 | Hyperglycemia | 241 | Patient |
| 2023 | High Blood Pressure/ Hypertension | 2 | Patient |
| 2023 | Hemoptysis | 1 | Patient |
| 2023 | Heart Failure/Congestive Heart Failure | 2 | Patient |
| 2023 | Headache | 4 | Patient |
| 2023 | Fatigue | 7 | Patient |
| 2023 | Elevated ketones/Diabetic Ketoacidosis | 26 | Patient |
| 2023 | Dyspnea | 3 | Patient |
| 2023 | Dizziness | 2 | Patient |
| 2023 | Distress | 2 | Patient |
| 2023 | Discomfort | 1 | Patient |
| 2023 | Diarrhea | 2 | Patient |
| 2023 | Diaphoresis | 1 | Patient |
| 2023 | Dehydration | 1 | Patient |
| 2023 | Cramp(s) /Muscle Spasm(s) | 1 | Patient |
| 2023 | Confusion/ Disorientation | 11 | Patient |
| 2023 | Concussion | 1 | Patient |
| 2023 | Chronic Obstructive Pulmonary Disease (COPD) | 1 | Patient |
| 2023 | Cardiac Arrest | 2 | Patient |
| 2023 | Cancer | 1 | Patient |
| 2023 | Blurred Vision | 5 | Patient |
| 2023 | Arrhythmia | 1 | Patient |
| 2023 | Appropriate Term / Code Not Available | 7 | Patient |
| 2023 | Anxiety | 3 | Patient |
| 2023 | Abdominal Pain | 2 | Patient |
| 2023 | Wireless Communication Problem | 8 | Device |
| 2023 | Visual Prompts will not Clear | 4 | Device |
| 2023 | Use of Device Problem | 10 | Device |
| 2023 | Unintended Movement | 7 | Device |
| 2023 | Unexpected Therapeutic Results | 2 | Device |
| 2023 | Priming Problem | 29 | Device |
| 2023 | Power Problem | 462 | Device |
| 2023 | Patient Device Interaction Problem | 5 | Device |
| 2023 | Overheating of Device | 1 | Device |
| 2023 | Obstruction of Flow | 331 | Device |
| 2023 | No Display/Image | 190 | Device |
| 2023 | Moisture or Humidity Problem | 49 | Device |
| 2023 | Mechanical Problem | 140 | Device |
| 2023 | Mechanical Jam | 9 | Device |
| 2023 | Material Integrity Problem | 89 | Device |
| 2023 | Manufacturing, Packaging or Shipping Problem | 2 | Device |
| 2023 | Loss of Data | 2 | Device |
| 2023 | Key or Button Unresponsive/not Working | 16 | Device |
| 2023 | Insufficient Information | 31 | Device |
| 2023 | Insufficient Flow or Under Infusion | 62 | Device |
| 2023 | Human-Device Interface Problem | 1 | Device |
| 2023 | Failure of Device to Self-Test | 2 | Device |
| 2023 | Excess Flow or Over-Infusion | 22 | Device |
| 2023 | Environmental Compatibility Problem | 5 | Device |
| 2023 | Electrical /Electronic Property Problem | 10 | Device |
| 2023 | Display or Visual Feedback Problem | 37 | Device |
| 2023 | Device Markings/Labelling Problem | 3 | Device |
| 2023 | Device Difficult to Program or Calibrate | 125 | Device |
| 2023 | Device Alarm System | 28 | Device |
| 2023 | Date/Time-Related Software Problem | 5 | Device |
| 2023 | Connection Problem | 16 | Device |
| 2023 | Computer Software Problem | 2 | Device |
| 2023 | Communication or Transmission Problem | 4 | Device |
| 2023 | Circuit Failure | 6 | Device |
| 2023 | Break | 412 | Device |
| 2023 | Battery Problem | 100 | Device |
| 2023 | Appropriate Term/Code Not Available | 302 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 144 | Device |
| 2022 | Vomiting | 7 | Patient |
| 2022 | Swelling/ Edema | 1 | Patient |
| 2022 | Skin Erosion | 1 | Patient |
| 2022 | Polydipsia | 2 | Patient |
| 2022 | Nausea | 4 | Patient |
| 2022 | Myocardial Infarction | 2 | Patient |
| 2022 | Muscle Weakness/Atrophy | 2 | Patient |
| 2022 | Malaise | 2 | Patient |
| 2022 | Loss of consciousness | 6 | Patient |
| 2022 | Liver Damage/Dysfunction | 1 | Patient |
| 2022 | Insufficient Information | 38 | Patient |
| 2022 | Inflammation | 1 | Patient |
| 2022 | Hypothermia | 1 | Patient |
| 2022 | Hypoglycemia | 22 | Patient |
| 2022 | Hyperglycemia | 47 | Patient |
| 2022 | High Blood Pressure/ Hypertension | 1 | Patient |
| 2022 | Fatigue | 2 | Patient |
| 2022 | Elevated ketones/Diabetic Ketoacidosis | 16 | Patient |
| 2022 | Dizziness | 2 | Patient |
| 2022 | Diaphoresis | 2 | Patient |
| 2022 | Dementia | 1 | Patient |
| 2022 | Confusion/ Disorientation | 6 | Patient |
| 2022 | Coma | 4 | Patient |
| 2022 | Cardiac Arrest | 2 | Patient |
| 2022 | Blurred Vision | 1 | Patient |
| 2022 | Arthritis | 1 | Patient |
| 2022 | Appropriate Term / Code Not Available | 14 | Patient |
| 2022 | Anxiety | 1 | Patient |
| 2022 | Anemia | 1 | Patient |
| 2022 | Wireless Communication Problem | 13 | Device |
| 2022 | Visual Prompts will not Clear | 12 | Device |
| 2022 | Use of Device Problem | 8 | Device |
| 2022 | Unintended Movement | 10 | Device |
| 2022 | Unexpected Therapeutic Results | 2 | Device |
| 2022 | Unauthorized Access to Computer System | 1 | Device |
| 2022 | Solder Joint Fracture | 1 | Device |
| 2022 | Priming Problem | 11 | Device |
| 2022 | Power Problem | 513 | Device |
| 2022 | Patient Device Interaction Problem | 1 | Device |
| 2022 | Overheating of Device | 3 | Device |
| 2022 | Obstruction of Flow | 243 | Device |
| 2022 | No Display/Image | 301 | Device |
| 2022 | No Apparent Adverse Event | 11 | Device |
| 2022 | Moisture or Humidity Problem | 55 | Device |
| 2022 | Mechanical Problem | 103 | Device |
| 2022 | Mechanical Jam | 8 | Device |
| 2022 | Material Integrity Problem | 155 | Device |
| 2022 | Manufacturing, Packaging or Shipping Problem | 1 | Device |
| 2022 | Loss of or Failure to Bond | 1 | Device |
| 2022 | Loss of Data | 6 | Device |
| 2022 | Key or Button Unresponsive/not Working | 1 | Device |
| 2022 | Intermittent Loss of Power | 1 | Device |
| 2022 | Insufficient Information | 8 | Device |
| 2022 | Insufficient Flow or Under Infusion | 56 | Device |
| 2022 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2022 | Human-Device Interface Problem | 3 | Device |
| 2022 | Failure of Device to Self-Test | 3 | Device |
| 2022 | Excess Flow or Over-Infusion | 22 | Device |
| 2022 | Environmental Compatibility Problem | 2 | Device |
| 2022 | Electrical /Electronic Property Problem | 14 | Device |
| 2022 | Display or Visual Feedback Problem | 31 | Device |
| 2022 | Device Markings/Labelling Problem | 2 | Device |
| 2022 | Device Difficult to Program or Calibrate | 113 | Device |
| 2022 | Device Alarm System | 18 | Device |
| 2022 | Date/Time-Related Software Problem | 5 | Device |
| 2022 | Connection Problem | 11 | Device |
| 2022 | Computer Software Problem | 16 | Device |
| 2022 | Communication or Transmission Problem | 15 | Device |
| 2022 | Circuit Failure | 13 | Device |
| 2022 | Calibration Problem | 1 | Device |
| 2022 | Break | 374 | Device |
| 2022 | Battery Problem | 86 | Device |
| 2022 | Appropriate Term/Code Not Available | 193 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 279 | Device |
| 2021 | Neck Pain | 3 | Patient |
| 2021 | Insufficient Information | 30 | Patient |
| 2021 | Hypoglycemia | 6 | Patient |
| 2021 | Hyperglycemia | 1 | Patient |
| 2021 | Elevated ketones/Diabetic Ketoacidosis | 1 | Patient |
| 2021 | Appropriate Term / Code Not Available | 5 | Patient |
| 2021 | Wireless Communication Problem | 2 | Device |
| 2021 | Unintended Movement | 8 | Device |
| 2021 | Priming Problem | 1 | Device |
| 2021 | Power Problem | 45 | Device |
| 2021 | Patient Device Interaction Problem | 4 | Device |
| 2021 | Obstruction of Flow | 65 | Device |
| 2021 | No Display/Image | 118 | Device |
| 2021 | No Apparent Adverse Event | 6 | Device |
| 2021 | Moisture or Humidity Problem | 5 | Device |
| 2021 | Mechanical Problem | 19 | Device |
| 2021 | Mechanical Jam | 3 | Device |
| 2021 | Material Integrity Problem | 113 | Device |
| 2021 | Loss of Data | 1 | Device |
| 2021 | Key or Button Unresponsive/not Working | 1 | Device |
| 2021 | Insufficient Information | 2 | Device |
| 2021 | Insufficient Flow or Under Infusion | 13 | Device |
| 2021 | Excess Flow or Over-Infusion | 6 | Device |
| 2021 | Electrical /Electronic Property Problem | 3 | Device |
| 2021 | Display or Visual Feedback Problem | 2 | Device |
| 2021 | Device Difficult to Program or Calibrate | 9 | Device |
| 2021 | Device Alarm System | 4 | Device |
| 2021 | Date/Time-Related Software Problem | 1 | Device |
| 2021 | Connection Problem | 4 | Device |
| 2021 | Computer Software Problem | 1 | Device |
| 2021 | Communication or Transmission Problem | 2 | Device |
| 2021 | Circuit Failure | 5 | Device |
| 2021 | Break | 182 | Device |
| 2021 | Battery Problem | 34 | Device |
| 2021 | Appropriate Term/Code Not Available | 33 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 13 | Device |
| 2020 | Vomiting | 2 | Patient |
| 2020 | Renal Failure | 1 | Patient |
| 2020 | Nausea | 2 | Patient |
| 2020 | Malaise | 2 | Patient |
| 2020 | Loss of consciousness | 3 | Patient |
| 2020 | Insufficient Information | 26 | Patient |
| 2020 | Hypoglycemia | 1 | Patient |
| 2020 | Hyperglycemia | 13 | Patient |
| 2020 | Fatigue | 2 | Patient |
| 2020 | Elevated ketones/Diabetic Ketoacidosis | 7 | Patient |
| 2020 | Appropriate Term / Code Not Available | 6 | Patient |
| 2020 | Abdominal Cramps | 2 | Patient |
| 2020 | Wireless Communication Problem | 1 | Device |
| 2020 | Power Problem | 3 | Device |
| 2020 | Patient Device Interaction Problem | 1 | Device |
| 2020 | Obstruction of Flow | 2 | Device |
| 2020 | No Apparent Adverse Event | 1 | Device |
| 2020 | Material Integrity Problem | 3 | Device |
| 2020 | Manufacturing, Packaging or Shipping Problem | 1 | Device |
| 2020 | Insufficient Flow or Under Infusion | 4 | Device |
| 2020 | Connection Problem | 1 | Device |
| 2020 | Break | 68 | Device |
| 2020 | Appropriate Term/Code Not Available | 45 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 5 | Device |