The U.S. Food and Drug Administration (FDA) has issued a warning that certain Medtronic MiniMed insulin pumps have the potential to be hacked, allowing a unauthorized third party to change the pump settings. Medtronic is recalling the following pumps and providing alternative pumps to users:
Pump Model | Software Version |
---|---|
MiniMed™ 508 | All versions |
MiniMed™ Paradigm™ 511 | All versions |
MiniMed™ Paradigm™ 512/712 | All versions |
MiniMed™ Paradigm™ 515/715 | All versions |
MiniMed™ Paradigm™ 522/722 | All versions |
MiniMed™ Paradigm™ 522K/722K | All versions |
MiniMed™ Paradigm™ 523/723 | Version 2.4A or lower |
MiniMed™ Paradigm™ 523K/723K | Version 2.4A or lower |
MiniMed™ Paradigm™ 712E* | All versions |
MiniMed™ Paradigm™ Veo 554CM/754CM* | Version 2.7A or lower |
MiniMed™ Paradigm™ Veo 554/754* | Version 2.6A or lower |
* Available outside the United States only.
Steps for determining the software version of your pump are available in this MiniMed patient letter. If your pump is part of the recall, you should speak with your health-care provider about switching to a different model and should call Medtronic at (866) 222-2584 with any questions.
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According to the FDA, to decrease the risk of your pump being hacked while you are waiting for a replacement, you should take the following steps:
• Keep your pump and all connected devices in your control whenever possible.
• Do not share the pump serial number.
• Pay attention to pump alarms, alerts and notifications.
• Check your blood glucose levels and respond accordingly.
• Immediately cancel any unintended boluses.
• Connect the pump to Medtronic devices and software only.
• Disconnect the USB device from the computer when you are not using it to download pump data.
If you have symptoms of severe hypoglycemia or diabetic ketoacidosis, or you think your pump settings have changed unexpectedly, you should get medical help right away.
To learn more about the pump recall, see the notice on the FDA website or the Medtronic MiniMed website.
Diane Fennell
Senior Digital Editor for DiabetesSelfManagement.com, Fennell has 16 years’ experience specializing in diabetes and related health conditions. Based in New York City, she has a degree from Columbia University.