FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)
MDR report key: 20678949
·
Received November 13, 2024
Report
- Report Number
- 3013756811-2024-216616
- Event Type
- Malfunction
- Date Received
- November 13, 2024
- Date of Event
- October 31, 2024
- Report Date
- November 13, 2024
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- PMA / PMN Number
- K203234
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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. DURING TROUBLESHOOTING WITH TECHNICAL SUPPORT, THE MALFUNCTION ALARM WAS CLEARED, AND INSULIN DELIVERY WAS RESUMED SUCCESSFULLY. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP INDICATED A DATA LOG CORRUPTION. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 243-244 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1204299 | T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP) | ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1000354 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | Male |