The Medicines and Healthcare Products Regulatory Agency (MHRA) posted a medical device safety alert concerning Accu-Chek Insight insulin pump cartridge (self-filled) manufactured by Roche Diagnostics. [Lot Numbers: 1083036, 1083193, 1083533, 1083534, 1083535, 1083536, 1083537, 1089205, 1089206, 1090593, 1090763, 1091203, 1091204, D04032014, D14112013]
The manufacturer has become aware of a potential insulin leakage occurring with some manufacturing lots of the Accu-Chek Insight insulin pump cartridge (self-filled) used with the Accu-Chek Insight insulin pump system. The potential risk is smaller than expected doses of insulin may be delivered if insulin leakage occurs. Patient may experience too high blood glucose levels, which if left untreated, can result in a diabetic ketoacidosis. Death could result.
The manufacturer is advising end users not to use and discard any cartridges of the above listed lots.
According to the local supplier, the affected products are not distributed in Hong Kong.
For details, please refer to the following link:
http://mhra.filecamp.com/public/file/28bg-c089h6uh
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 03 March 2015