FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 16208918
·
Received January 19, 2023
Report
- Report Number
- 3013756811-2023-10574
- Event Type
- Malfunction
- Date Received
- January 19, 2023
- Date of Event
- December 29, 2022
- Report Date
- January 19, 2023
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00850006613717
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS CRACKED AND UNREADABLE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 150-250 MG/DL. THE CUSTOMER WILL CONTINUE TO USE CURRENT PUMP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 406738 | T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1002717 | 00850006613717 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Male |