The Medicines and Healthcare Products Regulatory Agency (MHRA) has advised that certain lots of the Accu-Chek® Insight Tender infusion set are being recalled due to a potential issue of the patch not being sticky enough.
These are lots of the Accu-Chek Insight Tender infusion set used with the Accu-Chek Insight diabetes therapy system. This may lead to the headset becoming loose or falling off the skin potentially resulting in an unnoticed interruption of the insulin delivery.
While the number of reports related to the patches being not sticky enough remains very low, a voluntary recall for the potentially affected manufacturing lots has been put in place.
See below for the lot numbers of the potentially affected manufacturing lots.
1121511, 1124214, 1124218, 1124312, 1125243, 1125247, 1125249, 1125251, 1125253, 1128423, 1128427, 1128433, 1128435, 1128437, 1133656, 1135074
The lot number can be found on the package of the Accu-Chek Insight Tender infusion sets.
If an unnoticed interruption of the insulin flow occurs due to the patch being not sticky enough, this could result in smaller than expected doses of insulin. If a pump user receives lower-than-programmed dosages of insulin they may experience too high blood glucose levels which if left untreated, can result in a hyperglycemia or a diabetic ketoacidosis (DKA) with a serious outcome.
The following actions are listed below:
1. Please discontinue the use of any Accu-Chek Insight Tender infusion sets of the above listed lots immediately and contact your healthcare professional to determine how to continue your insulin pump therapy.
2. Please discard any unused infusion sets of the listed lots.
3. Please contact your local Accu-Chek Customer Care line (0800 731 22 91) or sales representative, if you have been provided with infusion sets from the lots listed above which are affected by this issue. You willreceive detailed instructions for an urgent replacement of the affected infusion sets at no cost for you.
4. As a replacement you will receive the Accu-Chek Insight Flex infusion set. This infusion set has a different design, cannula and patch glue that will offer you a safe and satisfactory continuation of your pump therapy. Accu-Chek Insight Flex can be used with Accu-Chek LinkAssist Plus for automatic cannula insertion. You will also receive a comprehensive training on how to use this new infusion set by your healthcare provider.
5. If you have experienced allergic reactions to patches in the past, please inform your Accu-Chek Customer Care agent or sales representative about it.
If you discover the Accu-Chek Insight Tender infusion set patch being not sticky enough:
1. Treat any high blood glucose level based on guidelines and recommendations provided by your healthcare professional.
2. Call the Accu-Chek Customer Care line at 0800 731 22 91 to report the issue. You will receive instructions on how to replace the affected infusion sets free of charge.
No other infusion sets offered for Accu-Chek insulin pump systems are affected by this issue. These are fine and safe to use.