MAUDE manufacturer profile
ROCHE DIAGNOSTICS · PPM
MAUDE profile for General Purpose Reagent
Key facts
| Manufacturer | ROCHE DIAGNOSTICS |
|---|---|
| Manufacturer group | ROCHE DIAGNOSTICS GMBH |
| Product code | PPM |
| Product code name | General Purpose Reagent |
At a glance
- 1–9 MAUDE reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- Irritation, Leak/Splash, Low Test Results, Incorrect Or Inadequate Test Results, Chemical Exposure, No Known Impact Or Consequence To Patient, Device Handling Problem, No Clinical Signs, Symptoms or Conditions 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