FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY
MDR report key: 24136124
·
Received January 21, 2026
Report
- Report Number
- 3013756811-2026-12299
- Event Type
- Malfunction
- Date Received
- January 21, 2026
- Date of Event
- January 15, 2026
- Report Date
- January 21, 2026
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00389152286716
- PMA / PMN Number
- K250792
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
ADDED A141204.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE BATTERY GAUGE WAS FLUCTUATING. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE VALUE. THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE BATTERY GAUGE WAS FLUCTUATING RESULTING IN THE PUMP SHUTTING DOWN. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE VALUE. THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 202078 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | 00389152286716 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Male |