FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)
MDR report key: 19117456
·
Received April 16, 2024
Report
- Report Number
- 3013756811-2024-62073
- Event Type
- Malfunction
- Date Received
- April 16, 2024
- Date of Event
- March 21, 2024
- Report Date
- April 16, 2024
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00389152000077
- PMA / PMN Number
- K203234
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT THE WAKE BUTTON WAS STICKING. CUSTOMER APPLIED MORE FORCE TO THE BUTTON TO RESOLVE THE ISSUE; HOWEVER, THE BUTTON WAS STILL DIFFICULT TO PRESS. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED RESULTING IN THE PUMP SHUTTING OFF. THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 120-322 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1368525 | T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP) | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | 00389152000077 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Female |