Starting from 1 January 2022, safety alerts related to medical devices listed under MDACS that have potential serious health risk/ public health risk to local population are listed below.
Medical device manufacturer, Medtronic has issued a medical device safety alert concerning its MiniMed 600 series pump systems. The affected devices include the following:
The manufacturer is informing users of a potential issue associated with the communication protocol used by the patient’s pump system. Unauthorized access to the communication protocol on the patient’s pump could compromise the pump’s delivery of insulin. The MiniMed 600 series pump system consists of components such as the pump, continuous glucose monitoring (CGM) transmitter, blood glucose meter and CareLink USB device that communicate wirelessly. The manufacturer has recently identified a potential issue through internal testing whereby, under specific circumstances, the communication between the components of the pump system could be compromised through unauthorized access.
If you are in possession of the affected products, please contact the supplier for necessary actions.
Posted on 23 Sep 2022