Events

Safety Alert Or Field Safety Notices for Accu-Chek Mobile meter and Accu-Chek Mobile test cassette

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/2014/021
  • Event Number
    CON425103
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON425103?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
    This device may give falsely high readings. as a consequence, patients might take an inappropriately high dose of insulin. the meter uses strip-free technology so users need to follow a specific testing procedure that is different to standard meter and strip systems. roche has sent its field safety notice (fsn), with updated instructions, to registered patients, healthcare professionals, distributors and retailers. the instructions are also online: www.Accu-chek.Co.Uk/mobilepropertesting (external link) this meter has been distributed in the uk since 2010.
  • Action
    Identify patients who use these meters and advise them to follow the correct testing procedure, details of which have been provided in the FSN. Ensure that patients can continue to monitor their blood glucose. If patients are concerned about their blood glucose readings when using this meter, advise them to contact their healthcare professional.

Device

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

Manufacturer

Roche