TRUEyou blood glucose test strips – risk of false low blood glucose results

1 July 2016

The MHRA have issued a Medical Device Alert regarding home use of blood glucose monitoring system: TRUEyou blood glucose test strips and the risk of false low blood glucose results. Certain lots of test strips may give incorrect low blood glucose results that could lead to undetected hyperglycaemia.

Action:

  • identify patients who use TRUEyou and TRUEyou mini blood glucose meters
  • advise patients to discontinue use of any blood glucose test strips with affected lot numbers
  • return affected test strips to manufacturer for replacement
  • ensure that patients are aware of this ifnormation and that they have an alternative testing means, if required
  • ensure the patient can continue to monitor their blood glucose effectively
  • if patients are concerned about their blood glucose readings when using this meter, advise them to contact their healthcare professional

For more information, including a list of affected lot numbers, please refer to MHRA Medical Device Alert MDA/2016/009R