MAUDE manufacturer profile
ROCHE DIABETES CARE, INC. · FPA
MAUDE profile for Set, Administration, Intravascular
Key facts
| Manufacturer | ROCHE DIABETES CARE, INC. |
|---|---|
| Manufacturer group | GERRESHEIMER REGENSBURG GMBH |
| Product code | FPA |
| Product code name | Set, Administration, Intravascular |
At a glance
- 1,000+ MAUDE reports
- 100–999 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Hyperglycemia, No Consequences Or Impact To Patient, Fluid/Blood Leak, Leak/Splash, No Clinical Signs, Symptoms or Conditions, Loss of or Failure to Bond, Failure To Adhere Or Bond, No Known Impact Or Consequence To Patient 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