PARADIGM REAL -TIME INSULIN INFUSION PUMP

by Unknown

DiabetesFDA 510kOn market since 2015
80
Low Risk

The PARADIGM REAL -TIME INSULIN INFUSION PUMP by Unknown has a safety score of 80 out of 100, placing it in the low-risk category. Based on FDA MAUDE data, there have been 82 adverse event reports since its introduction in 2015. With an estimated 0 units in use, the incident rate is 0 per 10,000 units. It ranks #19 out of 221 devices in the Diabetes category.

Adverse Events

82

Total reports filed with FDA MAUDE

Death Reports

0

Death reports associated with device

Incident Rate

0

Per 10,000 units in use

Recalls

0

No recalls on record

Estimated Units in Use

0

Based on market data estimates

Category Ranking

#19 of 221

In Diabetes by safety score

How This Compares

Safety Score80/100
Category Average
68
This Device
80
Best in Category
83

Important Context

Adverse event reports reflect reported incidents, not confirmed device failures. Higher numbers may indicate greater device usage, better reporting systems, or increased awareness. This data should be one factor in your research — always consult your physician.