FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 14978015
·
Received July 11, 2022
Report
- Report Number
- 3013756811-2022-68808
- Event Type
- Malfunction
- Date Received
- July 11, 2022
- Date of Event
- June 17, 2022
- Report Date
- June 18, 2022
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
DEVICE NOT RETURNED.
Description of Event or Problem · 0
IT WAS REPORTED THAT RESISTANCE WAS FELT WHEN FILLING THE CARTRIDGE DURING THE LOAD SEQUENCE. REPORTEDLY, THE CARTRIDGE AND SYRINGE NEEDLE WERE CHANGED TO ADDRESS THE ISSUE. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 180-217 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2013970 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Male | INFUSION SET: TRUSTEEL, INSULIN: NOVOLOG/NOVORAPID |