T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

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