Events

Recall of OMNIPOD INSULIN MANAGEMENT SYSTEM - PERSONAL DIABETES MANAGER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by INSULET CORPORATION.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    52319
  • Event Risk Class
    I
  • Event Initiated Date
    2014-03-04
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The freestyle blood glucose test strips when used with the freestyle blood glucose meter built into the omnipod insulin management system may produce erroneously low blood glucose results. erroneously low results that are not recognized may pose significant risks to a user's health.

Device

OMNIPOD INSULIN MANAGEMENT SYSTEM - PERSONAL DIABETES MANAGER
  • Model / Serial
    Model Catalog: CAT45F (Lot serial: All lots); Model Catalog: PDM-CAT35E (Lot serial: All lots); Model Catalog: PDM-CAT35F (Lot serial: All lots); Model Catalog: CAT45E (Lot serial: All lots)
  • Product Description
    OmniPod Insulin Management System
  • Manufacturer
    INSULET CORPORATION

Manufacturer

INSULET CORPORATION