FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 16830873
·
Received April 28, 2023
Report
- Report Number
- 3013756811-2023-59451
- Event Type
- Malfunction
- Date Received
- April 28, 2023
- Date of Event
- April 8, 2023
- Report Date
- April 28, 2023
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613762
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, 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 AN O-RING WAS ON THE PNEUMATIC TAP. THE CUSTOMER WAS ABLE TO REMOVE THE O-RING FROM THE PUMP AND SUCCESSFULLY LOADED A NEW CARTRIDGE TO RESOLVE THIS ISSUE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 250-299 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 430298 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | 00850006613762 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Female |