MAUDE manufacturer profile

BECKMAN COULTER MISHIMA K.K. · JJE

MAUDE profile for Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Key facts

Manufacturer BECKMAN COULTER MISHIMA K.K.
Manufacturer group BECKMAN COULTER MISHIMA K.K.
Product code JJE
Product code name Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

At a glance

  • 100–999 MAUDE reports
  • 10–99 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Known Impact Or Consequence To Patient, Incorrect, Inadequate or Imprecise Result or Readings, High Test Results, No Consequences Or Impact To Patient, Low Test Results, No Patient Involvement, Charred, Electrical Shorting 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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