MAUDE manufacturer profile
ABBOTT GMBH · JJE
MAUDE profile for Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Key facts
| Manufacturer | ABBOTT GMBH |
|---|---|
| Manufacturer group | ABBOTT GMBH |
| Product code | JJE |
| Product code name | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Incorrect, Inadequate or Imprecise Result or Readings, No Patient Involvement, No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Low Test Results, High Test Results, False Positive Result, No Consequences Or Impact 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