MAUDE manufacturer profile
I-SENS, INC. · NBW
MAUDE profile for System, Test, Blood Glucose, Over The Counter
Key facts
| Manufacturer | I-SENS, INC. |
|---|---|
| Manufacturer group | I-SENS WONJU FACTORY |
| Product code | NBW |
| Product code name | System, Test, Blood Glucose, Over The Counter |
At a glance
- 100–999 MAUDE reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Low Readings, High Readings, Hypoglycemia, Hyperglycemia, No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Low Test Results, High Test Results 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