Events

Recall of ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP

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

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
    130695
  • Event Risk Class
    II
  • Event Initiated Date
    2014-10-08
  • 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
    Roche has received customer complaints related to defective capacitor where date and time setting were lost and power interruption typically upon battery change if the user does not set date and time correctly after restart of an affected pump as stated in the manual the pump may deliver medication based on a time shifted basal profile.

Device

ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP
  • Model / Serial
    Model Catalog: 05027250001 (Lot serial: ALL SERIAL NUMBERS)
  • Product Description
    ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP
  • Manufacturer
    ROCHE DIAGNOSTICS

Manufacturer

ROCHE DIAGNOSTICS
  • Manufacturer Address
    LAVAL
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Source
    HC