FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 11812592
·
Received May 12, 2021
Report
- Report Number
- 3013756811-2021-47989
- Event Type
- Malfunction
- Date Received
- May 12, 2021
- Date of Event
- April 19, 2021
- Report Date
- May 12, 2021
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00853052007264
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS UNRESPONSIVE. AT THE TIME OF THE REPORT WITH TANDEM TECHNICAL SUPPORT THE TOUCH SCREEN WAS FUNCTIONING AS INTENDED; THEREFORE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 241-357 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 708609 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | 00853052007264 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | INFUSION SET: AUTOSOFT 90, INSULIN: HUMALOG |