FDA Adverse Event
Injury
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 15085193
·
Received July 22, 2022
Report
- Report Number
- 3013756811-2022-77812
- Event Type
- Injury
- Date Received
- July 22, 2022
- Date of Event
- April 24, 2022
- Report Date
- July 3, 2022
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- PMA / PMN Number
- K201214
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
REMOVE MDR CODES: 11, 4118, 3233.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS CRACKED AND UNREADABLE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 212 - 420 MG/DL. CUSTOMER WENT TO THE EMERGENCY ROOM (ER) ON (B)(6) 2022 WITH DIABETIC KETOACIDOSIS AND NOT BEING ABLE TO READ TOUCH SCREEN AND DELIVERED INCORRECT AMOUNT OF INSULIN VIA BOLUS. CUSTOMER WAS TREATED INTRAVENOUSLY WITH FLUIDS OF SALINE AND INSULIN. THE CUSTOMER WAS RELEASED FROM ER WITH ISSUE RESOLVED AND CUSTOMER REVERTED TO AN ALTERNATE METHOD IN INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 555537 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1000354 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Male | Required Intervention |