FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 15214058
·
Received August 11, 2022
Report
- Report Number
- 3013756811-2022-85982
- Event Type
- Malfunction
- Date Received
- August 11, 2022
- Date of Event
- July 21, 2022
- Report Date
- July 21, 2022
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613205
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.
Description of Event or Problem · 0
IT WAS REPORTED THAT A CARTRIDGE ALARM 1 OCCURRED DURING BOLUS. ADDITIONALLY, IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 122-177 MG/DL. THE CUSTOMER REVERTED TO ALTERNATE THERAPY FOR DIABETES MANAGEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2133251 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | W0102372 | 00850006613205 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Female |