FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 11227020
·
Received January 25, 2021
Report
- Report Number
- 3013756811-2021-08114
- Event Type
- Malfunction
- Date Received
- January 25, 2021
- Date of Event
- December 21, 2020
- Report Date
- January 25, 2021
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00853052007264
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT MULTIPLE INTERMITTENT MINIMUM FILL NOTIFICATIONS OCCURRED AFTER THE USER FILLED THE CARTRIDGE WITH APPROXIMATELY 130 UNITS OF INSULIN DURING THE LOAD SEQUENCES. THE CUSTOMER RE-LOADED THE CARTRIDGES TO RESOLVE THE ISSUES. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 120-124 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 121775 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | 00853052007264 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR |