FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY
MDR report key: 22769750
·
Received August 11, 2025
Report
- Report Number
- 3013756811-2025-189211
- Event Type
- Malfunction
- Date Received
- August 11, 2025
- Date of Event
- August 2, 2025
- Report Date
- September 22, 2025
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00389152000077
- PMA / PMN Number
- K232380
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
A CALLER REPORTED A CARTRIDGE ALARM 20. THE CUSTOMER'S BLOOD GLUCOSE LEVEL DID NOT EXCEED 500 MG/DL (27.7 MMOL/L), SO THERE WAS NO ADVERSE IMPACT. CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2003787 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | 00389152000077 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR | Unknown | UNOMEDICAL - CARTRIDGE |