FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY
MDR report key: 11665192
·
Received April 14, 2021
Report
- Report Number
- 3013756811-2021-38124
- Event Type
- Malfunction
- Date Received
- April 14, 2021
- Date of Event
- March 21, 2021
- Report Date
- April 14, 2021
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613700
- PMA / PMN Number
- DEN180058
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AIR BUBBLES WERE OBSERVED IN THE INFUSION SET TUBING. TANDEM TECHNICAL SUPPORT GUIDED THE CUSTOMER THROUGH PRIMING THE AIR BUBBLES OUT. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 232-311 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 563742 | T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | 00850006613700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | INFUSION SET: AUTOSOFT XC |