MAUDE brand profile

PARADIGM REALTIME REVEL INSULIN INFUSION PUMPD

MAUDE brand safety profile

Key facts

Brand name PARADIGM REALTIME REVEL INSULIN INFUSION PUMPD

At a glance

  • 1–9 MAUDE reports
  • 1–9 Injury reports
  • 1–9 Malfunction reports
  • 1–9 Problems coded
  • 1–9 Problems flagged by Orca1 signal analytics
  • Device Displays Incorrect Message, Hyperglycemia, No Known Impact Or Consequence To Patient, Adverse Event Without Identified Device or Use Problem, Device Alarm System, Elevated ketones/Diabetic Ketoacidosis, Hypoglycemia 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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