FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 22912521
·
Received August 28, 2025
Report
- Report Number
- 3013756811-2025-203811
- Event Type
- Malfunction
- Date Received
- August 28, 2025
- Date of Event
- August 24, 2025
- Report Date
- August 28, 2025
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613762
- PMA / PMN Number
- K203234
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT THERE WAS A MALFUNCTION ON THE PUMP. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. TECHNICAL SUPPORT SET UP A LOANER PUMP FOR THE CUSTOMER, WHO RELIED ON MANUAL INSULIN THERAPY UNTIL THE LOANER PUMP ARRIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1834560 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | 00850006613762 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Female |