MAUDE manufacturer profile

ROCHE DIAGNOSTICS · MMI

MAUDE profile for Immunoassay Method, Troponin Subunit

Key facts

Manufacturer ROCHE DIAGNOSTICS
Manufacturer group ROCHE DIAGNOSTICS GMBH
Product code MMI
Product code name Immunoassay Method, Troponin Subunit

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
  • High Test Results, No Clinical Signs, Symptoms or Conditions, Non Reproducible Results, No Consequences Or Impact To Patient, No Known Impact Or Consequence To Patient, Low Test Results, Incorrect, Inadequate or Imprecise Result or Readings, Incorrect Measurement 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

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