FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY
MDR report key: 23354350
·
Received October 21, 2025
Report
- Report Number
- 3013756811-2025-242059
- Event Type
- Malfunction
- Date Received
- October 21, 2025
- Date of Event
- October 16, 2025
- Report Date
- October 21, 2025
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00389152407319
- PMA / PMN Number
- K232380
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT AIR BUBBLES WERE OBSERVED WITHIN THE INFUSIONS SET TUBING. CUSTOMER PRIMED THE TUBING TO ADDRESS THE ISSUE. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 230099 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1000354 | 00389152407319 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Female | TANDEM - CARTRIDGE. |