MAUDE manufacturer profile

BECKMAN COULTER INC. · LRG

MAUDE profile for Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems

Key facts

Manufacturer BECKMAN COULTER INC.
Manufacturer group BECKMAN COULTER
Product code LRG
Product code name Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems

At a glance

  • 10–99 MAUDE reports
  • 1–9 Death reports
  • 1–9 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Incorrect, Inadequate or Imprecise Result or Readings, No Patient Involvement, No Known Impact Or Consequence To Patient, Incorrect Or Inadequate Test Results, Fire, Device Handling Problem, Smoking, Device Emits Odor 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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