GPs should advise all their patients with diabetes who use a particular LifeScan meter to measure their blood glucose that they should ask for a replacement, after the manufacturer found the devices had faulty software.
The UK Medicines and Healthcare Regulatory Agency announced yesterday it had been notified of the problem with Lifescan’s OneTouch Verio Pro and OneTouch Verio IQ meters used for self-monitoring and OneTouch Verio Pro+ meters used by healthcare professionals.
OneTouch Verio Pro meters with serial numbers beginning RA, RB, RC, RD and RE and OneTouch Verio IQ meters that have serial numbers beginning TA and TB are affected.
The manufacturer said the devices had 22,000 users in the UK and Ireland.
The MHRA said the software problem means that the devices fail at extremely high glucose levels of 56.8 mmol/l and above. The Pro device will give a falsely low glucose reading (56.8 mmol/l lower than the actual result) and the IQ device will countdown and switch off instead of displaying a result.
The Pro+ devices display a correct result at glucose levels 56.8 mmol/l but stores a falsely low reading.
An MHRA statement said: ‘LifeScan is recalling all OneTouchVerio blood glucose meters manufactured up to the 7 March 2013 and has written to patients and relevant healthcare professionals i.e. diabetes specialist nurses, GPs, practice nurses and pharmacists.’
GPs are advised to identify patients using affected meters and tell them to contact LifeScan customer care on 0800 279 9118 for a free replacement. In the meantime patients should use another meter to test their glucose.
A LifeScan spokesperson said: ‘While healthcare professionals wait for their replacement meter to arrive, they can continue to use their current OneTouch®Verio®Pro+ Meter because the test results and warning messages displayed at the time of the test are unaffected by this issue.
‘However, it is important that healthcare professionals do not rely on test results stored in the results log to make patient treatment decisions as they may be inaccurate.’
Pulse Live: 30 April – 1 May, Birmingham
Professor Martin Stevens, professor of medicine at the University of Birmingham, will look at the new developments in diabetes at Pulse Live, Pulse’s new two-day annual conference for GPs, practice managers and primary care managers.
Pulse Live offers practical advice on key clinical and practice business topics, as well as an opportunity to debate the future of the profession, and a top range of speakers includes NICE chair designate Professor David Haslam, GPC deputy chair Dr Richard Vautrey and the Rt Hon Stephen Dorrell MP, chair of the House of Commons health committee.
To find out more and book your place, please click here.