FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 13930057
·
Received March 28, 2022
Report
- Report Number
- 3013756811-2022-26980
- Event Type
- Malfunction
- Date Received
- March 28, 2022
- Date of Event
- March 4, 2022
- Report Date
- March 6, 2022
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
DEVICE NOT RETURNED.
Description of Event or Problem · 0
IT WAS REPORTED THAT INSULIN DRIPS WERE NOT OBSERVED TO BE EXITING THE INFUSION SET TUBING DURING THE LOAD FILL TUBING PROCESS. REPORTEDLY, THE PUMP SUPPLIES WERE CHANGED TO ADDRESS THE ISSUE AND INSULIN DELIVERY WAS RESUMED. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 180-217 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 298562 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | W0216793 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 YR | Male | INFUSION SET: TRUSTEEL, INSULIN: HUMALOG |