FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY
MDR report key: 10541601
·
Received September 16, 2020
Report
- Report Number
- 3013756811-2020-98766
- Event Type
- Malfunction
- Date Received
- September 16, 2020
- Date of Event
- August 24, 2020
- Report Date
- September 16, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613762
- PMA / PMN Number
- DEN180058
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 SUBMITTED UPON COMPLETION OF THE EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT A CARTRIDGE ALARM (ALARM 25) OCCURRED. REPORTEDLY, THE CUSTOMER DID NOT REMOVE THE CARTRIDGE DURING PUMPING. BLOOD GLUCOSE WAS BETWEEN 103-115 MG/DL. THE CUSTOMER SUCCESSFULLY RELOADED THE CARTRIDGE TO ADDRESS THE EVENT AND INSULIN DELIVERY WAS RESUMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1005204 | T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | 00850006613762 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |