PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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 | 9 | Patient |
2024 | Elevated ketones/Diabetic Ketoacidosis | 1 | Patient |
2024 | Wireless Communication Problem | 1 | Device |
2024 | Visual Prompts will not Clear | 2 | Device |
2024 | Unintended Movement | 1 | Device |
2024 | Power Problem | 40 | Device |
2024 | Obstruction of Flow | 5 | Device |
2024 | No Display/Image | 4 | Device |
2024 | Moisture or Humidity Problem | 2 | Device |
2024 | Mechanical Problem | 2 | Device |
2024 | Material Integrity Problem | 10 | Device |
2024 | Key or Button Unresponsive/not Working | 9 | Device |
2024 | Insufficient Information | 2 | Device |
2024 | Insufficient Flow or Under Infusion | 2 | Device |
2024 | Display or Visual Feedback Problem | 3 | Device |
2024 | Connection Problem | 1 | Device |
2024 | Computer Software Problem | 7 | Device |
2024 | Communication or Transmission Problem | 5 | Device |
2024 | Circuit Failure | 2 | Device |
2024 | Break | 9 | Device |
2024 | Battery Problem | 1 | Device |
2024 | Appropriate Term/Code Not Available | 8 | Device |
2024 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
2023 | Vomiting | 1 | Patient |
2023 | Nausea | 1 | Patient |
2023 | Loss of consciousness | 1 | Patient |
2023 | Hypoglycemia | 6 | Patient |
2023 | Hyperglycemia | 16 | Patient |
2023 | Fatigue | 1 | Patient |
2023 | Elevated ketones/Diabetic Ketoacidosis | 2 | 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 | 5 | Device |
2023 | Unexpected Therapeutic Results | 1 | Device |
2023 | Power Problem | 105 | Device |
2023 | Obstruction of Flow | 4 | Device |
2023 | No Display/Image | 17 | Device |
2023 | Moisture or Humidity Problem | 23 | Device |
2023 | Mechanical Problem | 12 | Device |
2023 | Material Integrity Problem | 31 | Device |
2023 | Loss of Data | 1 | Device |
2023 | Key or Button Unresponsive/not Working | 1 | Device |
2023 | Insufficient Information | 15 | Device |
2023 | Insufficient Flow or Under Infusion | 5 | Device |
2023 | Failure of Device to Self-Test | 2 | Device |
2023 | Excess Flow or Over-Infusion | 5 | Device |
2023 | Environmental Compatibility Problem | 1 | Device |
2023 | Electrical /Electronic Property Problem | 1 | Device |
2023 | Display or Visual Feedback Problem | 5 | Device |
2023 | Device Difficult to Program or Calibrate | 23 | Device |
2023 | Device Alarm System | 2 | Device |
2023 | Connection Problem | 2 | Device |
2023 | Computer Software Problem | 17 | Device |
2023 | Communication or Transmission Problem | 7 | Device |
2023 | Circuit Failure | 4 | Device |
2023 | Break | 38 | Device |
2023 | Battery Problem | 6 | Device |
2023 | Appropriate Term/Code Not Available | 25 | Device |
2023 | Adverse Event Without Identified Device or Use Problem | 12 | Device |
2022 | Vomiting | 1 | Patient |
2022 | Ventricular Fibrillation | 1 | Patient |
2022 | Renal Failure | 1 | Patient |
2022 | Polydipsia | 1 | Patient |
2022 | Malaise | 1 | Patient |
2022 | Loss of consciousness | 1 | Patient |
2022 | Hyperglycemia | 1 | Patient |
2022 | Fatigue | 1 | Patient |
2022 | Elevated ketones/Diabetic Ketoacidosis | 1 | Patient |
2022 | Convulsion, Clonic | 1 | Patient |
2022 | Wireless Communication Problem | 3 | Device |
2022 | Visual Prompts will not Clear | 6 | Device |
2022 | Use of Device Problem | 3 | Device |
2022 | Unintended Movement | 7 | Device |
2022 | Unauthorized Access to Computer System | 1 | Device |
2022 | Power Problem | 122 | Device |
2022 | Obstruction of Flow | 19 | Device |
2022 | No Display/Image | 17 | Device |
2022 | Moisture or Humidity Problem | 18 | Device |
2022 | Mechanical Problem | 17 | Device |
2022 | Mechanical Jam | 2 | Device |
2022 | Material Integrity Problem | 69 | Device |
2022 | Loss of Data | 3 | Device |
2022 | Intermittent Loss of Power | 2 | Device |
2022 | Insufficient Flow or Under Infusion | 2 | Device |
2022 | Human-Device Interface Problem | 1 | Device |
2022 | Failure of Device to Self-Test | 1 | Device |
2022 | Excess Flow or Over-Infusion | 1 | Device |
2022 | Environmental Compatibility Problem | 1 | Device |
2022 | Electrical /Electronic Property Problem | 6 | Device |
2022 | Display or Visual Feedback Problem | 3 | Device |
2022 | Device Difficult to Program or Calibrate | 17 | Device |
2022 | Device Alarm System | 1 | Device |
2022 | Date/Time-Related Software Problem | 1 | Device |
2022 | Connection Problem | 2 | Device |
2022 | Computer Software Problem | 42 | Device |
2022 | Communication or Transmission Problem | 29 | Device |
2022 | Circuit Failure | 3 | Device |
2022 | Break | 35 | Device |
2022 | Battery Problem | 9 | Device |
2022 | Appropriate Term/Code Not Available | 7 | Device |
2022 | Adverse Event Without Identified Device or Use Problem | 21 | Device |
2021 | Unintended Movement | 3 | Device |
2021 | Power Problem | 4 | Device |
2021 | Obstruction of Flow | 6 | Device |
2021 | Material Integrity Problem | 12 | Device |
2021 | Computer Software Problem | 3 | Device |
2021 | Communication or Transmission Problem | 2 | Device |
2021 | Break | 6 | Device |
2021 | Battery Problem | 2 | Device |