FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY
MDR report key: 24563689
·
Received March 10, 2026
Report
- Report Number
- 3013756811-2026-44964
- Event Type
- Malfunction
- Date Received
- March 10, 2026
- Date of Event
- March 3, 2026
- Report Date
- March 10, 2026
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00389152319810
- PMA / PMN Number
- K232380
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
HTTPS://EMDR.FDA.GOV/EMDR/FORMREDACTION/D11.JSF#.
Description of Event or Problem · 0
A CALLER REPORTED AN ISSUE OF NOT SEEING INSULIN DROPS AT THE END OF THE TUBING DURING THE FILL TUBING STEP OF THE LOAD SEQUENCE. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. REPORTEDLY, A SUPPLY CHANGE WAS PERFORMED TO ADDRESS THE ISSUE AND INSULIN DELIVERY WAS RESUMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 625582 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1000354 | 00389152319810 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Male | NOVOLOG / NOVORAPID - INSULIN| TANDEM - CARTRIDGE| UNOMEDICAL - INFUSION SET |