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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 091 08 18 000
Date submitted: 8/28/2018
Manufacturer:Medtronic
Device Type:MiniMed remote controller (MMT-500 or MMT-503)
Description:Insulin pump, remote controller
Medical Device Identifier:Model Nos.: MMT-500, MMT-503
Reason of Field Safety Corrective Action:An external security researcher has identified a potential vulnerability related to the MiniMed™ Paradigm™ family of insulin pumps and corresponding remote controller. The researcher’s report states that an unauthorized individual in close proximity of an insulin pump user could potentially copy the wireless radio frequency (RF) signals from the user’s remote controller (while they are in the process of delivering a remote bolus) and play those back later to deliver an involuntary bolus of insulin to the pump user. This could lead to potential health risks such as hypoglycemia if additional insulin is delivered beyond the user’s insulin requirements.
Remedy Action:Kindly check the precautionary steps in the attached FSN.
Athorized Representative/Importer/Distributor:Medtronic Saudi Arabia
Report Source:NCMDR
Source Ref. Number:B971F8E411317
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Medtronic.pdf