FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 24202023
·
Received January 28, 2026
Report
- Report Number
- 3013756811-2026-17359
- Event Type
- Malfunction
- Date Received
- January 28, 2026
- Date of Event
- January 23, 2026
- Report Date
- January 28, 2026
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00389152319513
- PMA / PMN Number
- K203234
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
IT WAS REPORTED OCCLUSION ALARMS OCCURRED. THE CUSTOMERS BLOOD GLUCOSE LEVEL WAS 211-228 MG/DL. REPORTEDLY, THE CUSTOMERS CURRENT CARTRIDGE HAS BEEN IN USE LONGER THAN RECOMMENDED, EDUCATION WAS PROVIDED BY TANDEM TECHNICAL SUPPORT TO CHANGE PUMP SUPPLIES WITHIN 72 HOURS. THE CUSTOMER CHANGED THE INFUSION SET AND CARTRIDGE, AND RESUMED INSULIN THERAPY. NO THIRD-PARTY ASSISTANCE WAS REQUIRED. ALTHOUGH EXPERIENCING RECURRING OCCLUSION ISSUES, THE CUSTOMER DECLINED FURTHER HELP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 261652 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | 00389152319513 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Female |