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Roche Diagnostics the subject of MHRA (UK Medicines and Healthcare products Regulatory Agency) device alert

This article was originally published in Clinica

Executive Summary

Roche Diagnostics' Accu-Chek Advantage II glucose test strips are the subject of a device alert issued by the UK Medicines and Healthcare products Regulatory Agency (MHRA). Healthcare providers and laboratories have been warned of a potential overestimation of glucose results in patients being treated with products containing maltose or metabolites of maltose. The fault can mask hypoglycaemia, resulting in an inappropriate administration of insulin. The MHRA reports three such incidents, including one fatality, all involving the Advantage II test strips, which may be used with Roche's Accu-Chek Advantage and Accu-Chek Inform point-of-care blood glucose monitors.

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