FDA Adverse Event
Injury
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 12577587
·
Received October 5, 2021
Report
- Report Number
- 3013756811-2021-107015
- Event Type
- Injury
- Date Received
- October 5, 2021
- Date of Event
- September 10, 2021
- Report Date
- October 5, 2021
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613762
- PMA / PMN Number
- K201214
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER INTERMITTENTLY EXPERIENCED A HIGH BLOOD GLUCOSE (BG) LEVEL OVER 500 MG/DL. REPORTEDLY, THE CUSTOMER ABSORBS INSULIN FASTER THAN THE PRESET 5 HOUR DURATION ON THE CONTROL IQ. A MANUAL INSULIN INJECTION WAS ADMINISTERED TO ADDRESS BG LEVEL. RECOMMENDATION WAS MADE TO DISCUSS DIABETES MANAGEMENT WITH A HEALTH CARE PROFESSIONAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1477739 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | 00850006613762 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Other |