FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 11565472
·
Received March 24, 2021
Report
- Report Number
- 3013756811-2021-31006
- Event Type
- Malfunction
- Date Received
- March 24, 2021
- Date of Event
- March 2, 2021
- Report Date
- March 24, 2021
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613205
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A MINIMUM FILL NOTIFICATION OCCURRED AFTER FILLING THE CARTRIDGE WITH 200 UNITS OF INSULIN. ADDITIONALLY, IT WAS REPORTED THAT THE INSULIN GAUGE WAS INTERMITTENTLY INACCURATE. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 163-386 MG/DL. THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 461505 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | 60272393 | 00850006613205 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR |