FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 9298421
·
Received November 8, 2019
Report
- Report Number
- 3013756811-2019-76379
- Event Type
- Malfunction
- Date Received
- November 8, 2019
- Date of Event
- October 18, 2019
- Report Date
- November 8, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00853052007325
- PMA / PMN Number
- P180008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER RECEIVED A POWER SOURCE ALERT AFTER PLUGGING THE PUMP INTO A WALL OUTLET. ADDITIONALLY, THE BATTERY GAUGE WAS OBSERVED TO BE FLUCTUATING. CUSTOMER¿S BLOOD GLUCOSE VALUE RANGED FROM 170-280 MG/DL. REPORTEDLY, THE CUSTOMER WILL CONTINUE TO USE THE PUMP AND HAS AN ALTERNATE METHOD OF INSULIN THERAPY AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1093419 | T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1000096 | 00853052007325 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR |