Accu-Chek Mobile glucose tests

Recall for product correction - potential for incorrect blood glucose results

22 April 2014

Consumers and health professionals are advised that Roche Diabetes Care, in consultation with the TGA, is undertaking a recall for product correction of its Accu-Chek Mobile glucose tests due to the potential for a commonly used antibiotic to interfere with blood glucose test results. Roche Diabetes Care is advising users of the Accu-Chek Mobile meter, a component of the glucose tests, of this issue and will be updating the devices' labelling.image of the device showing the date, time and reading

The Accu-Chek Mobile meter, pictured, is used by people receiving insulin therapy to monitor their blood glucose levels.

It has been identified that the antibiotic ceftriaxone can interfere with the way the measurement is made and may lead to incorrectly low blood glucose readings. Ceftriaxone is a broad-spectrum antibiotic used to treat a wide variety of common infections.

People who are using the Accu-Chek Mobile meter and are undergoing treatment with ceftriaxone are advised to discuss the issue with a health professional and to use an alternative blood glucose monitoring system for the duration of antibiotic treatment.

Roche Diabetes Care will offer affected patients a suitable alternative blood glucose measurement system for the duration of treatment with ceftriaxone at no charge.

Roche Diabetes Care's other blood glucose measurement systems are not affected by this recall for product correction.

Information for consumers

Consumers who are using the Accu-Chek Mobile meter and who are undergoing treatment with ceftriaxone are advised to seek advice from a health professional.

An alternative blood glucose monitoring system should be used for the duration of treatment with ceftriaxone at no charge.

If you have any questions, contact the company on 1800 251 816. Alternatively, you can speak to your diabetes nurse educator or other health professional.

Information for health professionals

Roche Diabetes Care Australia has written to relevant health professionals, professional organisations and consumers for whom it has contact details advising of this issue and has also published advertisements in the media.

The Accu-Chek Mobile meter is only prescribed to patients on insulin therapy.

If you are treating a diabetic patient with ceftriaxone please ensure they are aware of this issue. If they are using the Accu-Chek Mobile meter, advise them to seek out an alternative blood glucose monitoring system while taking this antibiotic.

If you or your patients have any questions, telephone the company on 1800 800 535.

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.