FreeStyle Papillon Mini blood glucose monitoring system
Further to the recall of two lots of FreeStyle Lite blood glucose test strips (below), which commenced on 25 November 2013, it has been identified that FreeStyle Papillon Mini blood glucose monitors can potentially give incorrect blood glucose results when used with any FreeStyle Lite test strip.
FreeStyle Papillon Mini blood glucose monitors have not been sold in Australia since 2009, but some of these devices may still be in use. Abbott Diabetes Care is providing consumers who still have a FreeStyle Papillon Mini blood glucose monitor with a new FreeStyle branded meter at no charge.
If you or someone you care for has a FreeStyle Papillon Mini blood glucose monitor, contact Abbott Diabetes Care on 1800 801 478 to arrange to receive a replacement device.
While you are waiting for your replacement device, if the only meter available to you is a FreeStyle Papillon Mini blood glucose monitor, do not stop testing your blood glucose levels. However, if any results appear lower than you would expect or do not seem to match the way you are feeling, contact your health professional.
If you are a health professional and are treating someone who uses a FreeStyle Papillon Mini blood glucose monitor, direct them to contact Abbott Diabetes Care on 1800 801 478.
Abbott Diabetes Care, in consultation with the TGA, is recalling two lots of its FreeStyle Lite blood glucose test strips due to the potential for giving incorrect blood glucose results when used with the Freestyle Papillon Mini blood glucose meter.
People with diabetes use disposable blood glucose test strips in conjunction with meters to measure their blood sugar levels.
The affected lots of FreeStyle Lite blood glucose test strips have the potential to give readings that are incorrectly low when used in conjunction with Freestyle Papillon Mini blood glucose meters. The issue does not occur when the strips are used with any other type of suitable meter (see the 'Additional information' section for more details) and the recall only affects users of Papillon Mini blood glucose meters.
An incorrectly low blood sugar reading could lead to unmanaged high blood sugar levels (hyperglycaemia). See the Information for Consumers section below for more detail on this condition.
The two lots of affected strips are:
- 1366540
- 1366621
The two affected lots were distributed in Australia in September and October 2013.
Information for consumers
To check whether you have blood glucose test strips from one of the affected lots, check the packaging for the affected batch numbers published above.
If you have affected strips and use the Freestyle Papillon Mini blood glucose meter call Abbott Diabetes Care Customer Service on 1800 801 478 for a free replacement. While waiting for your replacement strips to arrive, use an alternate method to measure your blood glucose (such as test strips from an unaffected lot number or a different blood glucose monitoring system).
This issue only affects the lot numbers published above when used with the FreeStyle Papillon Mini blood glucose meter. It does not occur when the strips are used with any other type of suitable meter (see the 'Additional information' section for more details).
If the only test strips available to you are from affected lots and you only have a FreeStyle Papillon Mini blood glucose meter available, do not stop testing your blood glucose. However, be aware that the reading could be lower than the true level. Pay special attention to signs and symptoms of high blood sugar (hyperglycaemia).
Symptoms of high blood sugar may include:
- excessive thirst
- excessive urination
- blurred vision
- weakness
- nausea
- vomiting
- abdominal pain.
If you are experiencing any of these symptoms or are not feeling well, contact your health care professional immediately.
If you have any questions or concerns about this issue, please phone Abbott Diabetes Care Customer Service on 1800 801 478. Alternatively, you can speak to your diabetes nurse educator or other health professional.
Information for health professionals
If you supply FreeStyle Lite blood glucose test strips, you should check the lot numbers of any that you have in your inventory. The affected lot numbers are in the main section above.
If you have any FreeStyle Lite blood glucose test strips from those lots, contact Abbott Diabetes Care Customer Service on 1800 801 478 to arrange return and replacement.
If you are treating a patient who may be using affected FreeStyle Lite blood glucose test strips, advise them of this issue. If they do have affected strips and a FreeStyle Papillon Mini blood glucose meter, advise them to either use an alternate method to measure their blood glucose (such as test strips from an unaffected lot number or a different blood glucose meter).
If patients do not have access to unaffected strips or an alternate method to measure blood glucose levels, advise them to continue using affected strips while they wait for replacements but to be aware of the potential for false low readings.
Advise them of the signs of hyperglycaemia and to seek treatment immediately if they experience them.
Additional information
FreeStyle Lite blood glucose test strips can also be used with FreeStyle Lite, FreeStyle Freedom Lite and FreeStyle InsuLinx meters. These meters incorporate newer technology and the incorrectly low reading issue has not affected them.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. 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.