FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)
MDR report key: 20077204
·
Received August 27, 2024
Report
- Report Number
- 3013756811-2024-154181
- Event Type
- Malfunction
- Date Received
- August 27, 2024
- Date of Event
- August 5, 2024
- Report Date
- August 27, 2024
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00389152000077
- PMA / PMN Number
- K203234
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. CUSTOMERS BLOOD GLUCOSE LEVEL WAS 250-299 MG/DL. DURING TROUBLESHOOTING WITH TECHNICAL SUPPORT, THE MALFUNCTION ALARM WAS CLEARED, AND INSULIN DELIVERY WAS RESUMED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 25181 | T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP) | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | 00389152000077 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Female |