FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 22496702
·
Received July 14, 2025
Report
- Report Number
- 3013756811-2025-166868
- Event Type
- Malfunction
- Date Received
- July 14, 2025
- Date of Event
- June 20, 2025
- Report Date
- July 24, 2025
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613779
- PMA / PMN Number
- K203234
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
REMOVE A070504, A110206, A150105, A1409.
Description of Event or Problem · 0
MACKENZIE TERRY REPORTED ISSUES WITH HER TANDEM PUMP, INCLUDING AN INABILITY TO COMPLETE THE SOFTWARE UPDATE, REDUCED BATTERY LIFE, A BATTERY THAT DRAINED WITHIN A DAY, AN INCLUSION ALARM, AND UNRESPONSIVE BUTTONS. THERE WAS NO ADVERSE IMPACT ON THE PATIENT¿S BLOOD GLUCOSE LEVEL. MACKENZIE EXPRESSED THAT SHE WAS OKAY TO CONTINUE USING THE CURRENT DEVICE AND INDICATED NO FOLLOW-UP WAS NECESSARY.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE WAKE BUTTON WAS DELAYED IN RESPONDING TO TOUCH. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT AND DECLINED TO PROVIDE FURTHER INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1420415 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | 00850006613779 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Female |