AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND
This device is manufactured by DEXCOM, TANDEM DIABETES CARE.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Wound Dehiscence | 1 | Patient |
| 2024 | Thrombosis | 1 | Patient |
| 2024 | Low Blood Pressure/ Hypotension | 1 | Patient |
| 2024 | Loss of consciousness | 1 | Patient |
| 2024 | Hypoglycemia | 20 | Patient |
| 2024 | Hyperglycemia | 58 | Patient |
| 2024 | Elevated ketones/Diabetic Ketoacidosis | 3 | Patient |
| 2024 | Convulsion/Seizure | 1 | Patient |
| 2024 | Use of Device Problem | 2 | Device |
| 2024 | Pumping Stopped | 245 | Device |
| 2024 | Poor Quality Image | 40 | Device |
| 2024 | Overheating of Device | 8 | Device |
| 2024 | Obstruction of Flow | 55 | Device |
| 2024 | No Display/Image | 2 | Device |
| 2024 | No Audible Alarm | 6 | Device |
| 2024 | Mechanical Problem | 14 | Device |
| 2024 | Material Twisted/Bent | 10 | Device |
| 2024 | Material Separation | 10 | Device |
| 2024 | Low Audible Alarm | 2 | Device |
| 2024 | Loose or Intermittent Connection | 54 | Device |
| 2024 | Leak/Splash | 7 | Device |
| 2024 | Insufficient Information | 7 | Device |
| 2024 | Insufficient Flow or Under Infusion | 1 | Device |
| 2024 | Incorrect Measurement | 166 | Device |
| 2024 | Inappropriate or Unexpected Reset | 7 | Device |
| 2024 | Imprecision | 1 | Device |
| 2024 | Fitting Problem | 31 | Device |
| 2024 | Filling Problem | 20 | Device |
| 2024 | False Alarm | 20 | Device |
| 2024 | Failure to Sense | 197 | Device |
| 2024 | Failure to Power Up | 7 | Device |
| 2024 | Difficult to Insert | 6 | Device |
| 2024 | Device Sensing Problem | 95 | Device |
| 2024 | Device Alarm System | 3 | Device |
| 2024 | Detachment of Device or Device Component | 9 | Device |
| 2024 | Date/Time-Related Software Problem | 61 | Device |
| 2024 | Data Problem | 8 | Device |
| 2024 | Crack | 42 | Device |
| 2024 | Communication or Transmission Problem | 51 | Device |
| 2024 | Charging Problem | 195 | Device |
| 2024 | Break | 15 | Device |
| 2024 | Battery Problem | 353 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 33 | Device |
| 2023 | Vomiting | 1 | Patient |
| 2023 | Urinary Retention | 1 | Patient |
| 2023 | Unspecified Kidney or Urinary Problem | 1 | Patient |
| 2023 | Unspecified Heart Problem | 1 | Patient |
| 2023 | Myocardial Infarction | 1 | Patient |
| 2023 | Loss of consciousness | 2 | Patient |
| 2023 | Insufficient Information | 5 | Patient |
| 2023 | Hypoglycemia | 44 | Patient |
| 2023 | Hyperglycemia | 84 | Patient |
| 2023 | Fall | 3 | Patient |
| 2023 | Elevated ketones/Diabetic Ketoacidosis | 10 | Patient |
| 2023 | Convulsion/Seizure | 1 | Patient |
| 2023 | Burn(s) | 1 | Patient |
| 2023 | Bone Fracture(s) | 2 | Patient |
| 2023 | Use of Device Problem | 1 | Device |
| 2023 | Temperature Problem | 7 | Device |
| 2023 | Scratched Material | 2 | Device |
| 2023 | Pumping Stopped | 627 | Device |
| 2023 | Poor Quality Image | 97 | Device |
| 2023 | Partial Blockage | 2 | Device |
| 2023 | Overheating of Device | 32 | Device |
| 2023 | Obstruction of Flow | 206 | Device |
| 2023 | No Audible Alarm | 9 | Device |
| 2023 | Melted | 3 | Device |
| 2023 | Mechanical Problem | 58 | Device |
| 2023 | Material Twisted/Bent | 8 | Device |
| 2023 | Material Separation | 12 | Device |
| 2023 | Material Frayed | 2 | Device |
| 2023 | Low Audible Alarm | 2 | Device |
| 2023 | Loose or Intermittent Connection | 235 | Device |
| 2023 | Leak/Splash | 20 | Device |
| 2023 | Insufficient Information | 8 | Device |
| 2023 | Insufficient Flow or Under Infusion | 2 | Device |
| 2023 | Incorrect Measurement | 544 | Device |
| 2023 | Inappropriate or Unexpected Reset | 34 | Device |
| 2023 | Improper Flow or Infusion | 3 | Device |
| 2023 | Imprecision | 3 | Device |
| 2023 | Fitting Problem | 58 | Device |
| 2023 | Fire | 1 | Device |
| 2023 | Filling Problem | 66 | Device |
| 2023 | False Alarm | 90 | Device |
| 2023 | Failure to Sense | 647 | Device |
| 2023 | Failure to Power Up | 5 | Device |
| 2023 | Excess Flow or Over-Infusion | 2 | Device |
| 2023 | Difficult to Insert | 18 | Device |
| 2023 | Device Sensing Problem | 245 | Device |
| 2023 | Device Alarm System | 9 | Device |
| 2023 | Detachment of Device or Device Component | 40 | Device |
| 2023 | Date/Time-Related Software Problem | 156 | Device |
| 2023 | Data Problem | 24 | Device |
| 2023 | Crack | 111 | Device |
| 2023 | Communication or Transmission Problem | 232 | Device |
| 2023 | Charging Problem | 558 | Device |
| 2023 | Break | 29 | Device |
| 2023 | Battery Problem | 696 | Device |
| 2023 | Application Security Problem | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 68 | Device |
| 2022 | Loss of consciousness | 1 | Patient |
| 2022 | Hypoglycemia | 8 | Patient |
| 2022 | Hyperglycemia | 9 | Patient |
| 2022 | Use of Device Problem | 2 | Device |
| 2022 | Temperature Problem | 19 | Device |
| 2022 | Pumping Stopped | 682 | Device |
| 2022 | Poor Quality Image | 72 | Device |
| 2022 | Physical Resistance/Sticking | 70 | Device |
| 2022 | Partial Blockage | 9 | Device |
| 2022 | Pacing Asynchronously | 1 | Device |
| 2022 | Output Problem | 1 | Device |
| 2022 | Obstruction of Flow | 183 | Device |
| 2022 | No Flow | 1 | Device |
| 2022 | No Audible Alarm | 1 | Device |
| 2022 | Mechanical Problem | 62 | Device |
| 2022 | Material Twisted/Bent | 1 | Device |
| 2022 | Material Separation | 10 | Device |
| 2022 | Material Frayed | 1 | Device |
| 2022 | Low Audible Alarm | 11 | Device |
| 2022 | Loose or Intermittent Connection | 128 | Device |
| 2022 | Leak/Splash | 19 | Device |
| 2022 | Insufficient Information | 13 | Device |
| 2022 | Insufficient Flow or Under Infusion | 1 | Device |
| 2022 | Incorrect Measurement | 518 | Device |
| 2022 | Inappropriate or Unexpected Reset | 36 | Device |
| 2022 | Improper Flow or Infusion | 9 | Device |
| 2022 | Fitting Problem | 29 | Device |
| 2022 | Filling Problem | 79 | Device |
| 2022 | False Alarm | 85 | Device |
| 2022 | Failure to Sense | 347 | Device |
| 2022 | Failure to Power Up | 9 | Device |
| 2022 | Failure to Auto Stop | 1 | Device |
| 2022 | Excess Flow or Over-Infusion | 3 | Device |
| 2022 | Difficult to Insert | 10 | Device |
| 2022 | Device Sensing Problem | 201 | Device |
| 2022 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2022 | Device Alarm System | 3 | Device |
| 2022 | Detachment of Device or Device Component | 17 | Device |
| 2022 | Defective Alarm | 1 | Device |
| 2022 | Date/Time-Related Software Problem | 77 | Device |
| 2022 | Data Problem | 39 | Device |
| 2022 | Crack | 75 | Device |
| 2022 | Communication or Transmission Problem | 255 | Device |
| 2022 | Charging Problem | 454 | Device |
| 2022 | Break | 42 | Device |
| 2022 | Battery Problem | 554 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 116 | Device |
| 2021 | Temperature Problem | 1 | Device |
| 2021 | Pumping Stopped | 1 | Device |
| 2021 | Poor Quality Image | 2 | Device |
| 2021 | Physical Resistance/Sticking | 4 | Device |
| 2021 | Obstruction of Flow | 2 | Device |
| 2021 | Loose or Intermittent Connection | 2 | Device |
| 2021 | Incorrect Measurement | 2 | Device |
| 2021 | Failure to Sense | 5 | Device |
| 2021 | Excess Flow or Over-Infusion | 1 | Device |
| 2021 | Device Sensing Problem | 2 | Device |
| 2021 | Device Dislodged or Dislocated | 1 | Device |
| 2021 | Data Problem | 1 | Device |
| 2021 | Crack | 1 | Device |
| 2021 | Communication or Transmission Problem | 3 | Device |
| 2021 | Charging Problem | 8 | Device |
| 2021 | Break | 1 | Device |
| 2021 | Battery Problem | 8 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 9 | Device |
| 2020 | Pumping Stopped | 2 | Device |
| 2020 | Physical Resistance/Sticking | 1 | Device |
| 2020 | Filling Problem | 1 | Device |
| 2020 | Communication or Transmission Problem | 1 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 3 | Device |