MAUDE manufacturer profile
ASCENSIA DIABETES CARE US INC. · JJX
MAUDE profile for Single (Specified) Analyte Controls (Assayed And Unassayed)
Key facts
| Manufacturer | ASCENSIA DIABETES CARE US INC. |
|---|---|
| Manufacturer group | BIONOSTICS, INC. BUSINESS TRADE NAME: RNA MEDICAL |
| Product code | JJX |
| Product code name | Single (Specified) Analyte Controls (Assayed And Unassayed) |
At a glance
- 100–999 MAUDE reports
- 1–9 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Incorrect, Inadequate or Imprecise Result or Readings, No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, Device Operates Differently Than Expected, Hyperglycemia, Display or Visual Feedback Problem, No Consequences Or Impact To Patient, Nonstandard Device 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