CDSCO raises cybersecurity alert on Medtronic remote controllers used in insulin pumps
New Delhi: Citing potential cybersecurity risks, the Central Drugs Standard Control Organization (CDSCO) has issued a Medical Device Alert for Medtronic's MMT-500 Remote Controller and MMT-503 Remote Controller used as an optional accessory with Ambulatory Insulin Infusion Pumps.
The Medical Device Alert comes in line with Medtronic's Field Safety Notice, which states that Remote Controllers Used with Paradigm and 508 MiniMed Insulin Pumps are being recalled due to Potential Cybersecurity Risks.
However, CDSCO has maintained that it has not received any complaints from the market regarding this issue.
In the field safety notice, Medtronic stated that people who have diabetes may use the MiniMed insulin pump to deliver insulin for the management of their diabetes. The pump system includes an optional remote controller device which is designed to communicate wirelessly with the pump to deliver a specific amount of insulin to the person with diabetes.
The Medtronic Minimed 508 pump and the 5xx and 7xx Series Paradigm Pump are ambulatory, battery powered, rate-programmable infusion pumps intended for continuous delivery of insulin at set and variable rates for the management of diabetes mellitus in people requiring insulin.
In addition to the delivery of insulin, the Paradigm pump is also designed to receive and display real-time glucose values received via a compatible transmitting device. Glucose values and pump history can be stored for subsequent download for further analysis of track patterns to improve diabetes management.
Issuing the safety alert, the CDSCO stated that Medtronic is recalling all remote controllers used with either the MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps due to potential cybersecurity risks.
As per the alert, "An unauthorized person (someone other than a patient, patient caregiver, or health care provider) could potentially record and replay the wireless communication between the remote and the MiniMed insulin pump."
"Using specialized equipment, an unauthorized person could instruct the pump to either over-deliver insulin to a patient, leading to low blood sugar (hypoglycemia}, or stop insulin delivery, leading to high blood sugar and diabetic ketoacidosis, even death." the alert added.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. In accordance with the field safety notice issued by Medtronic, the recalled products include all MiniMed Remote Controllers (models MMT-500 and MMT-503) used with a Medtronic MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps.
Further, as per the alert, the following people may be affected:
• Any person who uses the remote controller feature with either the MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps. The vulnerability is applicable to the MiniMed 508, MiniMed 511, MiniMed 512/712, M iniM ed515/715, MiniMed 522/722, MiniMed 523(K)/723(K), MiniMed 523/723 (Revel), MiniMed 554/754 (VEO), and MiniMed 551/751 (530G) pumps.
• Health care providers and caregivers who treat people with diabetes who use remote cont ro ller s associated with either the MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps.
In light of the foregoing, on October 5, 2021, Medtronic began notifying anyone who may still be using the MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps and has purchased a remote controller of the expanded recall.
To view the official alert, click the link below:
