The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has advised people using Roche’s CoaguChek device to check their test strips due to inaccurate results.
Roche has addressed the people regarding issue with the CoaguChek device, as a precautionary measure.
People on blood thinners using the CoaguChek device to test their blood clotting function must check their test strips, said MHRA.
CoaguChek XS PT Test, CoaguChek PT Test and CoaguChek XS PT PST test strips are suspected to produce inaccurate International Normalised Ratio (INR) results.
The use of problematic device may cause problems such as blood clots or an increased risk of bleeding, as a result of over or under-dose with anticoagulant medication.
The MHRA noted that anyone whose reading on their test strip is above 4.5 INR must discuss their results with a healthcare professional.
The regulator is also advising users to check the lot numbers of their test strips against the provided lot numbers and it is estimated that more than 125,000 packs were affected.
MHRA medical devices director John Wilkinson said: “If you’re worried about your readings when using these test strips, we’d recommend speaking to your GP, anticoagulant clinic or a pharmacist as soon as possible.
“Patient safety is our highest priority and we strongly encourage anyone to report any issues with this product, or more generally with any medical device, to our Yello Card Scheme.”
CoaguChek INRange is the firm’s new connected self-testing meter, which enables to test PT/INR at home, on the go and wherever needed.
The device’s Bluetooth technology enables to wirelessly transmit PT/INR results to the healthcare provider.
CoaguChek XS system is a convenient and portable instrument for monitoring oral anticoagulation therapy.
The device will be used to determine the INR value from a drop of capillary whole blood.
Roche also produces Accu-Chek products, including blood glucose systems for patient self-testing, including blood glucose monitors, test strips and lancing device.
The products also include comprehensive glucose monitoring systems, as well as diabetes data management for professional use.