Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The United Kingdom Medicines & Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning Medtronic MiniMed 600 and 700 series insulin pump [MiniMed 640G Insulin Pump; 670G Insulin Pump; 720G Insulin Pump, 740G Insulin Pump; 770G Insulin Pump; 780G Insulin Pump] [HKMD No. (for MiniMed 640G Insulin Pump only): 170311].
According to MHRA, the manufacturer is advising that for patients who have either received a new insulin pump or a replacement insulin pump in the last 6 months, the pump they received was NOT pre-programmed with their basal rates or other verified settings (i.e., bolus wizard settings, sensor settings, etc.), which must be set up and saved on their pump prior to use. The manufacturer advised the affected patients to carefully review the instructions provided and refer to the user guide in order to confirm that their settings have been saved and, if not, to program the insulin pump with these important settings and ensure that they are saved correctly.
For further information, please visit https://mhra-gov.filecamp.com/s/zzHw0oPRCltukI82/d.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 9 Feb 2022