MAUDE manufacturer profile
BETA BIONICS ORGANIZATION · QFG
MAUDE profile for Alternate Controller Enabled Insulin Infusion Pump
Key facts
| Manufacturer | BETA BIONICS ORGANIZATION |
|---|---|
| Manufacturer group | BETA BIONICS ORGANIZATION |
| Product code | QFG |
| Product code name | Alternate Controller Enabled Insulin Infusion Pump |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Hyperglycemia, Hypoglycemia, Insufficient Information, No Clinical Signs, Symptoms or Conditions, Use of Device Problem, Improper or Incorrect Procedure or Method, Elevated ketones/Diabetic Ketoacidosis, Diaphoresis 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