FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY
MDR report key: 25176866
·
Received May 14, 2026
Report
- Report Number
- 3013756811-2026-87826
- Event Type
- Malfunction
- Date Received
- May 14, 2026
- Date of Event
- May 12, 2026
- Report Date
- May 14, 2026
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00389152407111
- PMA / PMN Number
- K232380
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, 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. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 350 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 435630 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | 00389152407111 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |