Faulty FreeStyle InsuLinx diabetes meter warning
1st May 20133 -- The health watchdog, the Medicines and Healthcare products Regulatory Agency (MHRA), has issued a warning to people with diabetes about problems with FreeStyle InsuLinx blood glucose meters.
A software fault means a meter could give an incorrect low result if a rare but extremely high blood glucose level of 56.8 mmol/L and above is checked.
This blood glucose meter is manufactured by Abbott Diabetes Care and is used by up to 40,000 people.
This is the second alert about glucose meters in less than a month. This new safety alert follows one issued in April about two OneTouch Verio meters made by LifeScan.
The MHRA says the software fault could mean diagnosis and treatment are delayed.
Anyone with one of the meters at home they should contact Abbott Diabetes Care on 0800 088 5521 who will provide a new meter or give advice about updating the software.
In a statement on its website, Abbot Diabetes Care says: "We sincerely regret any inconvenience this situation may cause."
In a statement, John Wilkinson, the MHRA’s director of medical devices says: "People are unlikely to have very high blood glucose levels but if they do, they need a fully working blood glucose meter so they can get immediate medical attention."
Simon O’Neill, director of health intelligence at Diabetes UK, adds: "Blood glucose testing is an important part of diabetes management."
If people have concerns about their blood glucose readings, "they should consult with their diabetes care team," he says.