FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 23237918
·
Received October 7, 2025
Report
- Report Number
- 3013756811-2025-231751
- Event Type
- Malfunction
- Date Received
- October 7, 2025
- Date of Event
- October 1, 2025
- Report Date
- October 7, 2025
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- PMA / PMN Number
- K203234
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
A MALFUNCTION ALARM OCCURRED WITH THE CODE MALF 0. THE ISSUE DID NOT CAUSE THE CUSTOMER'S BLOOD GLUCOSE LEVEL TO EXCEED 500 MG/DL (27.7 MMOL/L), SO THERE WAS NO ADVERSE IMPACT. AS A RESOLUTION, CUSTOMER TECHNICAL SUPPORT DECIDED TO REPLACE THE PUMP. THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2746954 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |