FDA Adverse Event
Injury
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 15113436
·
Received July 27, 2022
Report
- Report Number
- 3013756811-2022-77756
- Event Type
- Injury
- Date Received
- July 27, 2022
- Date of Event
- July 3, 2022
- Report Date
- July 7, 2022
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- PMA / PMN Number
- K201214
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
DEVICE NOT RETURNED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED DIABETIC KETOACIDOSIS (DKA) RESULTING IN A HOSPITALIZATION; CAUSE OF DKA WAS NOT PROVIDED. A BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. REPORTEDLY, THE POSSIBLE CAUSE OF THE DKA WAS DUE TO DEGRADED INSULIN. CUSTOMER WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2022. MULTIPLE ATTEMPTS WERE MADE BY TANDEM¿S TECHNICAL SUPPORT TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, A RESPONSE FROM THE CUSTOMER WASN'T RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1870634 | 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 | 29 YR | Female | Required Intervention| H |