FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)
MDR report key: 20156419
·
Received September 6, 2024
Report
- Report Number
- 3013756811-2024-169472
- Event Type
- Malfunction
- Date Received
- September 6, 2024
- Date of Event
- August 31, 2024
- Report Date
- March 28, 2025
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- PMA / PMN Number
- K203234
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.
Description of Event or Problem · 0
IT WAS REPORTED THAT MULTIPLE CARTRIDGE ALARMS OCCURRED DURING INSULIN DELIVERY. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 113-233 MG/DL.
Description of Event or Problem · 0
IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING INSULIN DELIVERY. CUSTOMER LOADED A NEW CARTRIDGE TO RESOLVE THE ISSUE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 232-233 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2268439 | T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP) | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |