MAUDE manufacturer profile
TANDEM DIABETES CARE · QFG
MAUDE profile for Alternate Controller Enabled Insulin Infusion Pump
Key facts
| Manufacturer | TANDEM DIABETES CARE |
|---|---|
| Manufacturer group | DEXCOM, INC. |
| Product code | QFG |
| Product code name | Alternate Controller Enabled Insulin Infusion Pump |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Pumping Stopped, Charging Problem, Incorrect Measurement, Battery Problem, Obstruction of Flow, Hyperglycemia, Adverse Event Without Identified Device or Use Problem Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1