FDA Adverse Event
Injury
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 25094031
·
Received May 6, 2026
Report
- Report Number
- 3013756811-2026-82200
- Event Type
- Injury
- Date Received
- May 6, 2026
- Date of Event
- March 26, 2026
- Report Date
- May 6, 2026
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00389152000077
- PMA / PMN Number
- K203234
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT THE CUSTOMER HAD "OVER DELIVERED A BOLUS VIA THE PUMP RESULTING IN THE CUSTOMER'S BLOOD GLUCOSE DECREASING TO 19 MG/DL. CUSTOMER WENT TO EMERGENCY ROOM AND WAS TREATED WITH "SUGAR/GLUCIGON (LIKE OJ)". THE CUSTOMER WAS RELEASED LATER THAT SAME DAY WITH THE ISSUE RESOLVED AND THERE WAS NO PERMANENT DAMAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 270137 | 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 | 41 YR | Female | Required Intervention | LISPRO - INSULIN| UNOMEDICAL - INFUSION SET |