Nipro TRUEtrack and TRUEbalance blood glucose meters
Recall - replacement due to potential for miscalibration
Consumers and health professionals are advised that Nipro Australia, in consultation with the TGA, is recalling some models of its TRUEtrack and TRUEbalance blood glucose meters and replacing them with updated devices.
Nipro TRUEtrack and TRUEbalance blood glucose meters are primarily used for self-testing by patients with diabetes.
It has been identified that a small number of TRUEbalance and TRUEtrack blood glucose meters may have been incorrectly calibrated with the wrong unit of measure. Specifically, a miscalibrated meter would use mg/dL instead of mmol/L, which is the standard unit used in Australia.
If a patient did not notice the incorrect unit of measure, the meter result could be misread as being higher than the true figure. If this occurs, there is a risk of incorrect treatment including overmedication.
There had been no reports of adverse events related to this issue in Australia as at 23 October 2013.
The serial numbers of affected meters are:
No other blood glucose meters manufactured by Nipro Diagnostics are affected by this recall.
Information for consumers
This recall affects a number of TRUEtrack and TRUEbalance blood glucose meters that were distributed to NSW and Queensland patients by Diabetes Australia - NSW (now known as the Australian Diabetes Council). Nipro Australia has contacted all affected consumers to provide further information and to arrange replacement of their meters.
To confirm whether or not you have an affected device, check the serial number on the label on the back of the meter against the above list. If you think you may have an affected device but have not been contacted, or if you have any other questions, call Nipro Australia on 1800 451 737.
If you have an affected device, you should use an alternative method for measuring your blood glucose levels.
You can continue to use other blood glucose meters manufactured by Nipro Diagnostics that are not affected by this recall. However, you should only use test strips that are intended for use with your particular device.
Information for health professionals
If you supply TRUEtrack or TRUEbalance blood glucose meters, you should check the lot numbers (printed on the outer case/shipper label or on the side of the meter box) of any devices you have in your inventory. The affected lot numbers are published below and the serial numbers of affected meters contained within those lots are listed in the main section above.
If you have any TRUEtrack or TRUEbalance blood glucose meters from those lots, contact Nipro Australia on 1800 451 737 to arrange return and replacement of those devices.
If you are treating a patient who may be using an affected TRUEtrack or TRUEbalance blood glucose meter, advise them of this issue. If they do have an affected device, advise them to use an alternative method for measuring their blood glucose levels and to contact Nipro Australia on 1800 451 737 for further information.
Patients can continue to use other blood glucose meters manufactured by Nipro Diagnostics that are not affected by this recall. However, they should only use test strips that are intended for use with their particular device.
The lot numbers of affected meters are:
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.