FDA Adverse Event
Injury
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY
MDR report key: 22373582
·
Received July 1, 2025
Report
- Report Number
- 3013756811-2025-155579
- Event Type
- Injury
- Date Received
- July 1, 2025
- Date of Event
- June 26, 2025
- Report Date
- July 1, 2025
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00389152407111
- PMA / PMN Number
- K232380
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
CUSTOMER REPORTED A PAST LOW BLOOD GLUCOSE EVENT WITH THE LOWEST LEVEL REACHING 50S MG/DL. CUSTOMER MANAGED THE SITUATION BY DRINKING A MOUNTAIN DEW. TECHNICAL SUPPORT RECOMMENDED THAT THE CUSTOMER CONSULT THEIR HEALTHCARE PROVIDER TO DISCUSS POTENTIAL FACTORS AFFECTING THEIR BLOOD GLUCOSE LEVELS, AND THE CUSTOMER ACKNOWLEDGED THIS ADVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1270123 | 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 | 66 YR | Male | Other |