MAUDE brand profile

PARADIGM REALTIME REVEL INSULIN INFUSION PUMP

MAUDE brand safety profile

Key facts

Brand name PARADIGM REALTIME REVEL INSULIN INFUSION PUMP

At a glance

  • 1,000+ MAUDE reports
  • 1,000+ Death reports
  • 1,000+ Injury reports
  • 1,000+ Malfunction reports
  • 100–999 Problems coded
  • 100–999 Problems flagged by Orca1 signal analytics
  • Hyperglycemia, Device Displays Incorrect Message, No Known Impact Or Consequence To Patient, Hypoglycemia, Device Operates Differently Than Expected, Adverse Event Without Identified Device or Use Problem, No Display/Image, Device Inoperable Most reported problems

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE brand safety profiles

Brand profiles aggregate every MAUDE report that names the brand, so you can compare report volumes and problem patterns across devices. Reports are unverified and do not by themselves establish causation.

Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1

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