FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 16115005
·
Received January 6, 2023
Report
- Report Number
- 3013756811-2023-02200
- Event Type
- Malfunction
- Date Received
- January 6, 2023
- Date of Event
- December 15, 2022
- Report Date
- January 6, 2023
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00853052007264
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT A CARTRIDGE ALARM 1 OCCURRED DURING BASAL DELIVERIES. A REPLACEMENT PUMP WAS SENT TO THE CUSTOMER TO RESOLVE THE ISSUE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 130 - 169 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1459733 | T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1000096 | 60370929 | 00853052007264 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Female |