MAUDE manufacturer profile
BECKMAN COULTER, INC · MMI
MAUDE profile for Immunoassay Method, Troponin Subunit
Key facts
| Manufacturer | BECKMAN COULTER, INC |
|---|---|
| Manufacturer group | BECKMAN COULTER IRELAND, INC |
| Product code | MMI |
| Product code name | Immunoassay Method, Troponin Subunit |
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
- High Test Results, No Known Impact Or Consequence To Patient, No Code Available, Incorrect, Inadequate or Imprecise Result or Readings, No Consequences Or Impact To Patient, Incorrect Or Inadequate Test Results, Insufficient Information, False Positive Result 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