FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 13967123
·
Received March 31, 2022
Report
- Report Number
- 3013756811-2022-29477
- Event Type
- Malfunction
- Date Received
- March 31, 2022
- Date of Event
- October 7, 2021
- Report Date
- March 11, 2022
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
DEVICE NOT RETURNED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE WAKE BUTTON WAS INTERMITTENTLY UNRESPONSIVE. PUMP DISPLAY TURNED ON WHEN PLUGGED INTO A POWER SOURCE. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 162-181 MG/DL. CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1107647 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Male |