FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 24329321
·
Received February 12, 2026
Report
- Report Number
- 3013756811-2026-28829
- Event Type
- Malfunction
- Date Received
- February 12, 2026
- Date of Event
- February 8, 2026
- Report Date
- February 12, 2026
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613762
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
ADD A141204.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE CUSTOMER RECEIVED A POWER SOURCE ALERT WHILE USING THE TANDEM-PROVIDED USB CABLE AND TANDEM WALL ADAPTER RESULTING IN THE PUMP SHUTTING DOWN. REPORTEDLY, THE CUSTOMER WAS ABLE TO SUCCESSFULLY CHARGE THE PUMP USING AN ALTERNATE WALL ADAPTER AND USB CABLE. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE VALUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 390236 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | 00850006613762 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Male |