FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 14933331
·
Received July 6, 2022
Report
- Report Number
- 3013756811-2022-70678
- Event Type
- Malfunction
- Date Received
- July 6, 2022
- Date of Event
- June 16, 2022
- Report Date
- June 16, 2022
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613779
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND EVALUATION IS PERFORMED.
Description of Event or Problem · 0
IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. THE CUSTOMER'S BLOOD GLUCOSE RANGED FROM APPROXIMATELY 190-250. REPORTEDLY, THE CUSTOMER CONTINUED TO USE THE PUMP. THE CUSTOMER ALSO REPORTED THAT ALTERNATE INSULIN THERAPY WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 913836 | 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 | 29 YR | Female | INFUSION SET: AUTOSOFT 90INSULIN: HUMALOG |