MHRA medical device alert – CoaguChek Test Strips for Point of Care and Home Use (Roche Diagnostics GmbH)

MHRA medical device alert – CoaguChek Test Strips for Point of Care and Home Use (Roche Diagnostics GmbH)

October 8, 2018

MDA number: MDA/2018/033

Date issued 8th October 2018

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert:

CoaguChek Test Strips (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.

Affected batches: 

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 353606xx

Deadlines for actions

Actions underway: 15 October 2018

Actions complete: 22 October 2018

 

To view the alert please visit the GOV.UK website. 

 



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