MAUDE manufacturer profile
ANIMAS LLC · OYC
MAUDE profile for Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
Key facts
| Manufacturer | ANIMAS LLC |
|---|---|
| Manufacturer group | ANIMAS LLC |
| Product code | OYC |
| Product code name | Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, Structural Problem, Image Display Error/Artifact, Device Displays Incorrect Message, Moisture Damage, Fail-Safe Problem, Electrical /Electronic Property Problem, No Display/Image 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