FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 11440193
·
Received March 8, 2021
Report
- Report Number
- 3013756811-2021-27105
- Event Type
- Malfunction
- Date Received
- March 8, 2021
- Date of Event
- February 14, 2021
- Report Date
- March 8, 2021
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613212
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 AIR BUBBLES WERE OBSERVED IN THE INFUSION SET TUBING. CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS 230-245 MG/DL. CUSTOMER DELIVERED A BOLUS TO ADDRESS BG LEVEL AND CHANGED INFUSION SET. TANDEM TECHNICAL SUPPORT GUIDED THE CUSTOMER THROUGH PRIMING THE AIR BUBBLES OUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 330519 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | 00850006613212 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR |