MAUDE manufacturer profile
LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL · NBW
MAUDE profile for System, Test, Blood Glucose, Over The Counter
Key facts
| Manufacturer | LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL |
|---|---|
| Manufacturer group | LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL |
| Product code | NBW |
| Product code name | System, Test, Blood Glucose, Over The Counter |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Device Displays Incorrect Message, No Consequences Or Impact To Patient, Incorrect Or Inadequate Test Results, Loss of Power, Device Operates Differently Than Expected, High Test Results, Incorrect, Inadequate or Imprecise Result or Readings 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