FDA Adverse Event
Injury
Summary report: N
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)
MDR report key: 21300073
·
Received February 3, 2025
Report
- Report Number
- 3013756811-2025-25788
- Event Type
- Injury
- Date Received
- February 3, 2025
- Date of Event
- December 31, 2024
- Report Date
- March 13, 2025
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00389152319810
- PMA / PMN Number
- K203234
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
(H6) ADD CODES: 4121, 213, 67.
Additional Manufacturer Narrative · 0
NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE CUSTOMER WENT TO THE EMERGENCY ROOM (ER), REPORTEDLY DUE TO A LOW BLOOD GLUCOSE LEVEL, A SPECIFIC VALUE WAS NOT PROVIDED. CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT AND DECLINED TO PROVIDE FURTHER INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 64819 | T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP) | ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1000354 | 00389152319810 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Female | INSULIN TYPE: NOVOLOG / NOVORAPID |