Medical Device Alerts issued in April 2018; recent alert about Accu-Chek blood glucose test strips

An alert was issued recently about Accu-Chek Aviva, Accu-Chek Performa, and Accu-Chek Inform II test strips – risk of strip error messages and false high and low blood glucose results. An alert was also issued recently about Infinity Acute Care System and M540 Patient Monitors.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 24 May 2018

• Therapeutic area: Anaesthesia and intensive care, Cardiovascular disease and lipidology, Endocrinology, diabetology and metabolism, Haematology, Paediatrics and neonatology, Urology and nephrology

In this monthly update, we highlight selected Medical Device Alerts that have been issued recently by MHRA. Please note, this is not an exhaustive list of medical device alerts. For all Medical Device Alerts from MHRA, see Alerts and recalls for drugs and medical devices.

Alert were recently issued by MHRA about:

• Home use and Point of Care blood glucose monitoring system: Accu-Chek Aviva, Accu-Chek Performa and Accu-Chek Inform II test strips – risk of strip error messages and false high and low blood glucose results

• Infinity Acute Care System and M540 Patient Monitors software versions VG2.2-VG6.0 – risk that alarms are not activated

Article citation: Drug Safety Update volume 11 issue 10; May 2018: 4.

Published 24 May 2018