FDA Adverse Event
Malfunction
Summary report: N
TANDEM T SLIM INSULIN PUMP
MDR report key: 23405910
·
Received October 28, 2025
Report
- Report Number
- MW5178120
- Event Type
- Malfunction
- Date Received
- October 28, 2025
- Report Date
- December 4, 2025
- Manufacturer
- TANDEM DIABETES CARE, INC.
- Product Code
- QFG
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
- Health Professional
- *
Narratives
Description of Event or Problem · 0
MY DAUGHTER HAS A TANDEM T SLIM INSULIN PUMP AND HAS HAD 5 PUMPS FAIL ON HER IN THE LAST SEVERAL MONTHS. SHE EITHER HAS REALLY BAD LUCK OR SOMETHING HAS CHANGED OR IS WRONG WITH THE MANUFACTURER. PLEASE INVESTIGATE. PT CODE: 4582. DEVICE CODE: 2588. REFERENCE REPORTS: MW5178116, MW5178117, MW5178118, MW5178119.
Description of Event or Problem · 0
ADDITIONAL INFORMATION RECEIVED ON 12/3/2025 FOR REPORT NUMBER MW5178120 TO UPDATE PROCODE TO QFG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 214802 | TANDEM T SLIM INSULIN PUMP | ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP | QFG | TANDEM DIABETES CARE, INC. | T SLIM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Female |