MHRA medical device alert – Accu-Chek Aviva, Accu-Chek Performa and Accu-Chek Inform II test strips (Roche Diabetes Care)

MHRA medical device alert – Accu-Chek Aviva, Accu-Chek Performa and Accu-Chek Inform II test strips (Roche Diabetes Care)

May 18, 2018

MDA/2018/016

Date issued: 18th May 2018

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert for:

Accu-Chek Aviva, Accu-Chek Performa and Accu-Chek Inform II test strips (Roche Diabetes Care)

Affected test strips, manufactured by Roche Diabetes Care, may give increased strip error messages prior to dosing with blood and in some cases may give false high or low readings, which may be hard to detect.

Healthcare personnel who manage patients using these devices are advised by the MHRA to do the following:

  • Identify patients who use Accu-Chek Aviva, Accu-Chek Aviva Nano, Accu-Chek Aviva Expert, Accu-Chek Aviva Combo, Accu-Chek Aviva Insight, Accu-Chek Performa Nano meters.
  • Advise patients to discontinue use of Accu-Chek Aviva and Accu-Chek Performa blood glucose test strips with affected lot numbers (see the Field Safety Notice) and to return affected test strips to the pharmacy where they were dispensed or purchased from for replacements.
  • Ensure that patients are aware of this information 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.

Deadlines for actions:

Actions underway: 4th June 2018

Actions complete: 18th June 2018

To view the alert please visit the GOV.UK website.



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