FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 16274199
·
Received January 31, 2023
Report
- Report Number
- 3013756811-2023-11517
- Event Type
- Malfunction
- Date Received
- January 31, 2023
- Date of Event
- January 8, 2023
- Report Date
- January 31, 2023
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613762
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. ADDITIONALLY, IT WAS REPORTED THAT A MINIMUM FILL NOTIFICATION OCCURRED AFTER THE USER FILLED THE CARTRIDGE WITH 220 UNITS OF INSULIN DURING THE LOAD SEQUENCE. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 132-181 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1991407 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | 00850006613762 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Female |