FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 24322184
·
Received February 12, 2026
Report
- Report Number
- 3013756811-2026-27903
- Event Type
- Malfunction
- Date Received
- February 12, 2026
- Date of Event
- February 11, 2026
- Report Date
- May 11, 2026
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613304
- PMA / PMN Number
- K203234
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
REMOVE CODE A141204.
Description of Event or Problem · 0
CALLER REPORTED THAT A POWER SOURCE ALERT HAD OCCURRED. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. THE CUSTOMER TRIED USING DIFFERENT WALL ADAPTER AND CHARGING CABLE, BUT THESE ACTIONS DID NOT RESOLVE THE ISSUE. CONSEQUENTLY, TECHNICAL SUPPORT DECIDED TO REPLACE THE PUMP. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 576129 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | 00850006613304 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |