FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 17061727
·
Received June 5, 2023
Report
- Report Number
- 3013756811-2023-78007
- Event Type
- Malfunction
- Date Received
- June 5, 2023
- Date of Event
- May 15, 2023
- Report Date
- June 5, 2023
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00853052007264
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE AND STATIC. CUSTOMER CONTINUED TO USE THE EXISTING CARTRIDGE ON THE PUMP FOR INSULIN THERAPY. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS UNRESPONSIVE. CUSTOMER¿S BLOOD GLUCOSE LEVEL RANGED FROM 150-199 MG/DL. THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2293525 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1000096 | 00853052007264 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Female |