FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 11215963
·
Received January 22, 2021
Report
- Report Number
- 3013756811-2021-00948
- Event Type
- Malfunction
- Date Received
- January 22, 2021
- Date of Event
- December 30, 2020
- Report Date
- January 22, 2021
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613205
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, 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 A MALFUNCTION ALARM OCCURRED. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS BETWEEN 180-218 MG/DL. AT THE TIME OF THE REPORT WITH TANDEM TECHNICAL SUPPORT, THE CUSTOMER DID NOT HAVE AN ALTERNATE METHOD OF INSULIN THERAPY. UPON FOLLOW-UP, CUSTOMER STATED THAT THEY HAD BEEN UNABLE TO OBTAIN A PROPER BACK-UP THERAPY METHOD PRIOR TO RECEIVING THEIR REPLACEMENT PUMP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 115524 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | 00850006613205 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |