FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 11365383
·
Received February 23, 2021
Report
- Report Number
- 3013756811-2021-18341
- Event Type
- Malfunction
- Date Received
- February 23, 2021
- Date of Event
- January 31, 2021
- Report Date
- February 23, 2021
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613779
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT MULTIPLE CARTRIDGE ALARMS OCCURRED DURING THE LOAD SEQUENCE WITH MULTIPLE CARTRIDGES. ADDITIONALLY, IT WAS REPORTED THAT A CARTRIDGE CHANGE ERROR OCCURRED DURING THE LOAD SEQUENCE. SUBSEQUENTLY, A MALFUNCTION ALARM OCCURRED. CUSTOMER REVERTED TO AN ALTERNATE PUMP FOR INSULIN THERAPY. CUSTOMER'S BLOOD GLUCOSE RANGED FROM APPROXIMATELY 170-175 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 262241 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | 00850006613779 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR |