FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 11531075
·
Received March 19, 2021
Report
- Report Number
- 3013756811-2021-31471
- Event Type
- Malfunction
- Date Received
- March 19, 2021
- Date of Event
- February 28, 2021
- Report Date
- March 19, 2021
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00853052007264
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED DIFFICULTY CHARGING THE PUMP WITH THE USB CABLE AND WALL ADAPTER CAUSING PUMP SHUT OFF UNEXPECTEDLY. REPLACEMENT CHARGING CABLE AND WALL ADAPTER SENT TO CUSTOMER. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 212-220 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 424752 | T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1000096 | 00853052007264 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR |