FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 11257814
·
Received February 1, 2021
Report
- Report Number
- 3013756811-2021-11792
- Event Type
- Malfunction
- Date Received
- February 1, 2021
- Date of Event
- January 10, 2021
- Report Date
- February 1, 2021
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00853052007325
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PER THE TANDEM USER GUIDE: CHECK YOUR PUMP¿S PERSONAL SETTINGS REGULARLY TO ENSURE THEY ARE CORRECT. INCORRECT SETTINGS CAN RESULT IN OVER DELIVERY OR UNDER DELIVERY OF INSULIN. 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 PUMP CORRECTION FACTOR SETTING WAS PROGRAMMED INCORRECTLY. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, SETTING WAS CORRECTED AND INSULIN DELIVERY WAS SUCCESSFULLY RESUMED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 267 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 154891 | T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1000354 | 00853052007325 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR |