One of the biggest health problems in the black community is diabetes. And that problem is both helped and magnified by technology. The Food and Drug Administration is warning people using the Medtronic MiniMed insulin pumps that the devices are vulnerable to hacking.
The FDA has no evidence of the device being hacked…yet. But the warning clearly indicates this a growing health care cyber risk. Hackers could potentially change the pump’s settings causing dangerous fluctuations in the insulin delivery. The FDA advises patients using certain models of the pump to switch to less vulnerable ones.
Because of the seriousness of the issues Medtronic has issued a recall of MiniMed insulin pumps. The insulin pumps cannot be patched or updated. The device connects wirelessly to other insulin equipment including glucose meters, a monitoring system and controls that pump insulin. Therein lies the cyber security vulnerability.
The following devices are being recalled.
| 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 |
FDA Recommendations
The FDA has issued the following recommendation for caregivers and people with diabetes.
- Check to see if the model and software version of your insulin pump is affected. Read the Medtronic Patient LetterExternal Link Disclaimer to learn how to identify your pump’s software version. If you live outside the United States, Medtronic will send you a notification letter with instructions based on the country where you live.
- Talk to your health care provider about a prescription to switch to a model with more cybersecurity protection.
- If you have questions about replacing your pump, call Medtronic at 1-866-222-2584 or go to Medtronic’s websiteExternal Link Disclaimer
To minimize the potential risk of a cybersecurity attack while you are waiting for a replacement pump:
- Keep your insulin pump and the devices that are connected to your pump within your control at all times whenever possible.
- Do not share your pump serial number.
- Be attentive to pump notifications, alarms, and alerts.
- Monitor your blood glucose levels closely and act appropriately.
- Immediately cancel any unintended boluses.
- Connect your Medtronic insulin pump to other Medtronic devices and software only.
- Disconnect the USB device from your computer when you are not using it to download data from your pump.
Get medical help right away if you:
- Have symptoms of severe hypoglycemia (such as excessive sweating, feeling very tired, dizzy and weak, being pale, and a sudden feeling of hunger).
- Have symptoms of diabetic ketoacidosis (such as excessive thirst, frequent urination, nausea and vomiting, feeling very tired and weak, shortness of breath).
- Think your insulin pump settings or insulin delivery changed unexpectedly.
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