OneTouch Verio IQ blood glucose meter

Device recall

3 April 2013

Health professionals and consumers are advised that Johnson & Johnson Medical Pty Ltd, after consultation with the TGA, is recalling its OneTouch Verio IQ Blood Glucose Meter.

OneTouch Verio IQ Blood Glucose Meters are primarily used for self-testing by patients with diabetes.

Image of the OneTouch Verio IQ blood glucose meter deviceIt has been found that, at extremely high blood glucose levels (56.8 mmol/L and above), the device will turn off rather than display the intended warning "EXTREME HIGH GLUCOSE above 33.3 mmol/L". Once turned back on, the device enters set-up mode and requires the user to confirm the time and date settings. If another reading of 56.8 mmol/L or above is then registered, the device will turn off again.

The likelihood of experiencing blood glucose levels of 56.8 mmol/L and above is remote. However, such levels pose a serious health risk to the patient and require immediate medical attention. The identified fault in the OneTouch Verio IQ Blood Glucose Meter could lead to a delay in diagnosis and treatment of extremely high blood glucose levels and, consequently, result in serious injury.

Johnson & Johnson Medical Pty Ltd has initiated a consumer-level recall and is replacing all devices free of charge.

Information for consumers

Johnson & Johnson Medical Pty Ltd has sent a replacement device, along with further information, to patients who had previously registered their meter for warranty.

If you have a OneTouch Verio IQ Blood Glucose Meter and have not registered it for warranty, you should call 1800 543 372 to organise a replacement.

You can continue to test your blood glucose level with your OneTouch Verio IQ Blood Glucose Meter until you receive the replacement. However, if your device unexpectedly turns off and enters set-up mode when you turn it back on, your blood glucose level may be extremely high and you should seek immediate medical attention.

If you have any questions or concerns about blood glucose meters, please contact your diabetes nurse educator or other health professional.

Information for all health professionals

Johnson & Johnson Medical Pty Ltd has written to all diabetes nurse educators and distributors it has on record, providing further information regarding the recall process.

All OneTouch Verio IQ Blood Glucose Meters in stock should be quarantined before making arrangements with Johnson & Johnson Medical Pty Ltd to replace them.

If you have any questions or concerns about OneTouch Verio IQ Blood Glucose Meters, please call Johnson & Johnson Medical Pty Ltd on 1800 252 194.

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.