FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)
MDR report key: 20529155
·
Received October 24, 2024
Report
- Report Number
- 3013756811-2024-203298
- Event Type
- Malfunction
- Date Received
- October 24, 2024
- Date of Event
- October 16, 2024
- Report Date
- October 24, 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 AN ALTITUDE ALARM OCCURRED. REPORTEDLY, THE PUMP WAS NOT OUTSIDE THE LABELED ALTITUDE OPERATING RANGE. THE CUSTOMER'S BLOOD GLUCOSE WAS 252-253 MG/DL. REPORTEDLY, THE CARTRIDGE WAS RELOADED, AND INSULIN DELIVERY WAS RESUMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2567149 | 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 |