Important Information
Roch Diabetes Care has issued a field safety notice regarding the Accu-Chek Solo micropump system to avoid insulin leakage at the septum.
Description of Situation
Customer feedback revealed insulin leakage and high blood glucose values due to improper penetration of the septum of the cannula assembly by the connecting needle.
The current method of inserting the pump into the pump holder may lead to insulin leakage, resulting in high blood glucose values and potentially severe hyperglycaemia.
A new method for inserting the Accu-Chek Solo micropump into the pump holder, called the “turn-in method”, has been developed to decrease the risk of leakages significantly.
An addendum on the new turn-in method will be included in the product manual and dispatched to all current customers.
Users are advised to use the new turn-in method for inserting the Accu-Chek Solo micropump into the pump holder to avoid insulin leakage.
Manual:
Download: Urgent Field Safety Notice for Accu-Chek Solo micropump system
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