Events

Safety Alert Or Field Safety Notices for CoaguChek Test Strips for Point of Care and Home Use

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 Diagnostics GmbH.

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
  • Date
    2018-10-08
  • Event Date Posted
    2018-10-08
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/coaguchek-test-strips-for-point-of-care-and-home-use-risk-of-false-high-results-mda-2018-033
  • 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
    Roche Diagnostics has found an increasing positive bias with INR values above 4.5 for certain CoaguChek test strips. For INR values above 4.5 a medical risk of increased bleeding or thrombosis, due to inadequate therapeutic measures, cannot be excluded.The root cause is multifactorial. The detailed root cause analysis is still ongoing.Users are advised to confirm INR results above 4.5 by a laboratory method (venous blood sample) or unaffected CoaguChek test strips until replacement lots are available. Roche has confirmed that the impacted test strip lots can be used for results between 0.8 to 4.5 INR.MHRA is issuing this Medical Device Alert to make sure users know about this problem, are aware of the follow up FSN issued by Roche and know what updated actions to take. The follow up FSN replaces the one dated 22 August 2018.Roche has indicated that the following new lots, which are unaffected by this issue, are expected to be available to order in early/mid October 2018 for supply to the UK market in November 2018.First new lots which are unaffected by this issue (available in November 2018):CoaguChek XS PT PST Test, lots beginning with 334499xx
    CoaguChek XS PT Test, lots beginning with 334499xx
    CoaguChek PT Test, lots beginning with 361433xx
  • Reason
    Manufactured by roche diagnostics gmbh: affected coaguchek test strips may give false high results for inr values above 4.5 when compared to laboratory results, this may lead to incorrect treatment decisions.
  • Action
    Identify the affected strips listed in the manufacturer’s Field Safety Notice (FSN) and follow the instructions provided. For the affected test strips, confirm all INR results above 4.5 using a laboratory method or unaffected test strips. Increase testing frequency after therapy changes in line with local guidelines. Identify patients who use these devices at home and ensure they have received and understood the content of the manufacturer’s consumer letter. Ensure that all relevant members of staff receive the manufacturer’s FSN and that they understand the problem and actions to be taken. Report adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not.

Device

CoaguChek Test Strips for Point of Care and Home Use
  • Model / Serial
  • Product Description
    Roche has shown that the following products and lot numbers are affected by this issue:Product Lot Number (first six digits, as below) CoaguChek XS PT Test PST from 272167xx up to 334498xx CoaguChek XS PT Test from 272167xx up to 334498xx CoaguChek PT Test from 272170xx up to 353606xxThese devices are used in anti-coagulation clinics in hospitals and other non-clinical settings. They are also used by GPs, district nurses and patients at home.
  • Manufacturer
    Roche Diagnostics GmbH

Manufacturer

Roche Diagnostics GmbH
  • Manufacturer Address
    Roche Diagnostics Charles Avenue Burgess Hill West Sussex RH15 9RY Tel (Patients): 0808 100 7666 Tel (Technical Support Hotline UK - HCP): 0808 100 1920Email (Patients): burgesshill.coagpts@roche.comEmail (HCP): burgesshill.tsgpm@roche.com
  • Manufacturer Parent Company (2017)
    Roche Holding Ag
  • Source
    MHRA