LifeScan OneTouch Verio blood glucose monitoring system, 16 September 2011

Consumer recall

This is an update to the alert issued by the TGA on 16 June 2011. Johnson and Johnson have advised the TGA of additional serial numbers affected by the recall.

The Therapeutic Goods Administration (TGA) has been advised that some LifeScan OneTouch Verio Blood Glucose Monitoring Systems are giving repeated 'error 2' warning messages when used in conditions of high temperature and/or humidity. In these conditions the patient may not get a blood glucose result.

The additional units affected were manufactured on or before 4 January 2011 and are being recalled.

Information for patients and healthcare professionals

• If the affected unit does not give the error message, then the reading is reliable.
• Patients with LifeScan OneTouch Verio Blood Glucose Monitoring System should contact the OneTouch Customer Care line 1800 543 372 to have the affected units replaced and to get more information.
• Alternatively you can visit OneTouch and complete the form on the website.
• The replacement with an unaffected meter of the same model will be provided at no cost.
• The strips and the control test solution used with this meter are not affected by this recall.
• Information on how to report a suspected problem with a medicine or medical device to the TGA can be found at 'Reporting Problems'.

Additional information

As of 20 May 2011, 186 complaints (179 from Australia and 7 from overseas) have been received by the manufacturer which relate to the 'error 2' message.

Investigation by the manufacturer, LifeScan Inc, USA has shown that the problem is caused by contamination occurring across the Strip Port connector (SPC) pins of the meter. This manufacturing fault is due to the use of incorrect solder wire.

The Australian supplier, Johnson & Johnson Medical Pty Ltd will advertise information about the recall of the additionally affected serial numbers in major daily newspapers from 22 September 2011.