Press Release

Safety alert on ACCU-CHEK FlexLink Plus infusion sets

2 Mar 2011

The Department of Health (DH) today (March 2) warned the public not to use ACCU-CHEK FlexLink Plus infusion sets, manufactured by Roche Diagnostics, because of the potential for under delivery of insulin due to a kinked cannula when inserting the infusion set.

DH, through its routine surveillance on medical devices, noticed that Roche had announced a recall of the above product. Roche’s investigation into complaints regarding kinked cannulas revealed that in some cases the distance between the needle cut and the end of the soft cannula is too small and may contribute to an impaired cannula.

Malfunction of infusion sets may result in under delivery of insulin leading to elevation of blood glucose levels, or hyperglycemia. Symptoms of hyperglycaemia include nausea/vomiting, blurred vision, excessive thirst or hunger, frequent urination, fatigue, headache, etc.

A DH spokesman remarked that hyperglycemia is a significant health risk, as untreated hyperglycaemia may lead to death in serious cases. Although preliminary investigation revealed that there is neither record of marketing nor report of adverse events in Hong Kong, the dreaded consequence and the fact that there may be occasional patients here who have somehow obtained the devices overseas justify a public alert.

Roche Diagnostics (Hong Kong) Ltd has set up a hotline, 2485-7512, to answer public enquiries from 9am to 12noon, and from 2pm to 5pm between Monday and Friday.

Meanwhile, DH has informed all public and private hospitals, medical professional associations and healthcare professionals about the matter and advised them to remain vigilant.

The spokesman said: "DH will closely monitor the developments. Members of the public should consult their healthcare professionals for advice if in doubt or feel unwell."