In the warning posted Sept. 20, the FDA said that the Medtronic MiniMed 600 Series Insulin Pump System, including models such as MiniMed 630G and MiniMed 670G, have an equipment issue that may allow someone to break in and cause the pump to deliver too much or too little insulin to the patient.
For this to happen, an unauthorized person would need to gain access to a pump as it is pairing with other system components.
The FDA noted that this kind of incident has not been reported.
The FDA is working with Medtronic to identify, communicate and prevent this cybersecurity issue from happening.
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