Events

Safety Alert Or Field Safety Notices for Accu-Chek Compact meter and test strips, Accu-Chek Mobile meter and test cassette, Accu-Chek Active meter and test strips

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Roche.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2014/026
  • Event Number
    CON433897
  • Date
    2014-07-09
  • Event Date Posted
    2014-07-09
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON433897?tabName=allTabs
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
  • Reason
    The accu-chek compact, accu-chek mobile and accu-chek active devices may give falsely low blood glucose readings for patients receiving ceftriaxone therapy. roche has updated product leaflets for these devices and issued a field safety notice (fsn), distributed to healthcare professionals.
  • Action
    Identify diabetic patients on ceftriaxone therapy. Advise these patients and relevant healthcare staff not to use Accu-Chek Compact, Accu-Chek Mobile or Accu-Chek Active devices throughout the duration of treatment with ceftriaxone. Ensure that patients on ceftriaxone therapy use an alternative device during their treatment.

Device

Accu-Chek Compact meter and test strips, Accu-Chek Mobile meter and test cassette, Accu-Chek Acti...
  • Model / Serial
  • Product Description
    Home use blood glucose meters: Accu-Chek Compact meter and test strips Accu-Chek Mobile meter and test cassette Accu-Chek Active meter and test strips manufactured by Roche.
  • Manufacturer
    Roche

Manufacturer

Roche