FDA Adverse Event
Injury
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 22560945
·
Received July 21, 2025
Report
- Report Number
- 3013756811-2025-174760
- Event Type
- Injury
- Date Received
- July 21, 2025
- Date of Event
- April 9, 2025
- Report Date
- July 21, 2025
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00389152000091
- PMA / PMN Number
- K203234
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A BLOOD GLUCOSE (BG) LEVEL OF 800-900 MG/DL AND "TRAUMA" TO LIVER AND KIDNEYS. BG LEVEL WAS ADDRESSED WITH A CORRECTION BOLUS VIA THE PUMP. REPORTEDLY, THE CARTRIDGE AND INFUSION SET HAD BEEN IN USE FOR MORE THAN 48 HOURS WITH HUMALOG INSULIN. TANDEM TECHNICAL SUPPORT EDUCATED THE CUSTOMER ON INSULIN LABELING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2785170 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | 00389152000091 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Female | Other | HUMALOG - INSULIN |