Health professionals and consumers are advised that Roche Diagnostics Australia, after consultation with the TGA, has initiated a recall for product correction for its CoaguChek XS, CoaguChek XS Plus and CoaguChek XS Pro INR monitors.
CoaguChek INR monitors are used by health professionals and for self-testing by patients taking anticoagulant medicines, sometimes referred to as 'blood-thinners', such as warfarin.
A single case has been identified, in which a patient being treated with antibiotics and chemotherapeutics, in addition to their anticoagulant medicine, received an 'ERROR 6' message rather than the INR value while using a CoaguChek INR monitor. If this issue occurs, there is a risk that a patient's INR value could be extremely high and require medical attention without them knowing it.
An 'ERROR 6' message normally indicates test strip interference, such as the test strip being touched or removed during testing. However, in the above situation, the INR monitor was unable to differentiate the medicine interaction from the test strip interference.
The affected material numbers are:
- 04796179001
- 04811500001
- 04963733001
- 06505597001
- 04800842190
- 05864640001
- 06505589001
- 06644511001
- 05530199190
Roche Diagnostics Australia has contacted all patients with affected devices to notify them of this issue. Roche Diagnostics Australia will also be including updated information regarding 'ERROR 6' and revised recommendations of what to do if it occurs in the device's Instructions for Use and the package insert for CoaguChek XS PT strips, which are used in each of the affected models.
Information for consumers
This issue is very rare and that CoaguChek INR monitors are not being recalled from the market. If you have one of these devices, you can continue using it after noting the below information regarding its updated Instructions for Use.
If you have a CoaguChek INR monitor and get an 'ERROR 6' message, you are advised to repeat the test. If you continue to get the error message, and you are taking antibiotics and/or chemotherapeutics in addition to your anticoagulant medicine, your INR value could be extremely high, and you should contact your health professional without delay.
Roche Diagnostic Australia has written to all patients with affected devices, providing updated Instructions for Use.
If you have a CoaguChek INR monitor and have not received this information, or if you have any questions or concerns about your device, contact Roche Diagnostic Australia's technical support line on 1800 645 619.
Information for all health professionals
This issue is very rare, with only a single case identified (at a rate of less than 0.00015%).
A repeated 'ERROR 6' message is most likely to occur in patients with a high INR value who are being treated with antibiotics and/or chemotherapeutics in addition to their anticoagulant medicine. The issue could also occur for up to two days after treatment with antibiotics and/or chemotherapeutics is discontinued.
There is no data to suggest that an 'ERROR 6' message will occur if the patient's INR value is normal.
If you or a patient encounters an 'ERROR 6' message repeatedly while using a CoaguChek INR monitor in this situation, you should use alternative methods of monitoring the patient's INR value, such as referring them for laboratory testing.
If you have any questions or concerns about CoaguChek INR monitors, contact Roche Diagnostic Australia's technical support line on 1800 645 619.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.