FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY
MDR report key: 24038480
·
Received January 12, 2026
Report
- Report Number
- 3013756811-2026-06667
- Event Type
- Malfunction
- Date Received
- January 12, 2026
- Date of Event
- January 7, 2026
- Report Date
- January 12, 2026
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00389152407012
- PMA / PMN Number
- K250792
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
A CALLER REPORTED RECEIVING A MINIMUM FILL NOTIFICATION WHILE ATTEMPTING TO LOAD A NEW INSULIN CARTRIDGE. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. THE CALLER INITIALLY STRUGGLED WITH THE FILLING PROCESS DUE TO A LOW AMOUNT OF USABLE INSULIN IN THE CARTRIDGE. TECHNICAL SUPPORT INSTRUCTED THE CALLER TO ADD MORE INSULIN, AFTER WHICH THE CALLER SUCCESSFULLY LOADED A CARTRIDGE ONTO THE PUMP AND RESUMED INSULIN USE. HOWEVER, THE CUSTOMER LATER REPORTED ONGOING DIFFICULTIES WITH LOADING CARTRIDGES BUT MANAGED TO LOAD THE FOURTH CARTRIDGE SUCCESSFULLY DURING A FOLLOW-UP CALL. TECHNICAL SUPPORT ADVISED KEEPING THE TAP CLEAN TO PREVENT DEBRIS-RELATED ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 101277 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP | QFG | TANDEM DIABETES CARE | 00389152407012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Female |