FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 10953122
·
Received December 5, 2020
Report
- Report Number
- 3013756811-2020-135277
- Event Type
- Malfunction
- Date Received
- December 5, 2020
- Date of Event
- November 11, 2020
- Report Date
- December 4, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613762
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CARTRIDGE ALARM 06 OCCURRED WITH MULTIPLE CARTRIDGES. REPORTEDLY, THE PUMP WAS NOT OUTSIDE OF THE ALLOWABLE OPERATING ALTITUDE RANGE AT THE TIME OF THIS ALARM. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 110-240 MG/DL. CUSTOMER WAS UNABLE TO CLEAR THE ALARM AND REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1417302 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | M645413 | 00850006613762 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR |