FDA Adverse Event
Injury
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 22738400
·
Received August 7, 2025
Report
- Report Number
- 3013756811-2025-187262
- Event Type
- Injury
- Date Received
- August 7, 2025
- Date of Event
- July 8, 2025
- Report Date
- August 7, 2025
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- PMA / PMN Number
- K203234
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT THE CUSTOMER WENT TO THE EMERGENCY ROOM AND WAS SUBSEQUENTLY HOSPITALIZED DUE TO A DIABETES-RELATED ISSUE WHILE USING THE PUMP FOR INSULIN THERAPY. THE HIGHEST BLOOD GLUCOSE LEVEL NOTED DURING THE INCIDENT WAS 33 MMOL/L. NO ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE OUTCOME OF THE EVENT OR ANY FURTHER ACTIONS TAKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2219343 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization| R |