FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 23237686
·
Received October 7, 2025
Report
- Report Number
- 3013756811-2025-231714
- Event Type
- Malfunction
- Date Received
- October 7, 2025
- Date of Event
- May 20, 2025
- Report Date
- October 31, 2025
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- PMA / PMN Number
- K203234
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
INITIAL MDR WAS SUBMITTED INCORRECTLY. PLEASE DISREGARD MFG# 3013756811-2025-231714.
Description of Event or Problem · 0
CUSTOMER REPORTED THAT BATTERY ON THE DEVICE WAS NOT CHARGING, AND NO ADDITIONAL INFORMATION WAS PROVIDED. NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS NOTED. PUMP WAS RETURNED FOR FURTHER EXAMINATION, UPON PLUGGING IN THE PUMP, IT STARTED WITHOUT ANY ISSUES AND WAS RECOGNIZED BY THE COMPUTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1487624 | 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 |