Dear Doctor,
Please be informed that the Department of Health (DH) alerted the public on March 2 not to use ACCU-CHEK FlexLink Plus infusion sets, manufactured by Roche Diagnostics (Roche), because of the potential for under delivery of insulin due to a kinked cannula when inserting the infusion set.
Through our routine surveillance of medical devices, it was noticed that Roche has announced a recall of the above product (http://www.accu-chekinsulinpumps.com/dstrnc_us/rewrite/generalContent/en_US/article/DCM_general_article_125.htm). 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. This malfunction may result in under delivery of insulin leading to hyperglycaemia.
Please note although our preliminary investigation has revealed that there is neither record of marketing of the product nor report of such adverse events in Hong Kong, there may still be occasional patients here who have somehow obtained the devices overseas and potentially suffer from serious consequences.
Roche Diagnostics (Hong Kong) Ltd has set up a hotline, 2485 7512, to answer public enquiries from 9am to 12 noon, and from 2pm to 5pm between Monday and Friday.
DH will closely monitor the developments, and advises all healthcare professionals to remain vigilant regarding the matter.
Thank you for your attention.
Yours faithfully,
(Rachel YUE)
for Director of Health
Medical Device Control Office, Department of Health, HKSAR Government