MAUDE manufacturer profile
BETA BIONIC, INC. · QFG
MAUDE profile for Alternate Controller Enabled Insulin Infusion Pump
Key facts
| Manufacturer | BETA BIONIC, INC. |
|---|---|
| Manufacturer group | BETA BIONIC, INC. |
| Product code | QFG |
| Product code name | Alternate Controller Enabled Insulin Infusion Pump |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Hypoglycemia, Insufficient Information, Hyperglycemia, Loss of consciousness, Use of Device Problem, Elevated ketones/Diabetic Ketoacidosis, Dizziness, Confusion/ Disorientation 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