Medical Device Alert: CDSCO issues an alert on cyber security risks

Glucose values and pump history can be stored for subsequent download for further analysis of track patterns to improve diabetes management.

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CDSCO DCGI FDA

Last Updated on November 13, 2021 by The Health Master

The Central Drugs Standard Control Organisation (CDSCO) has issued an alert on 08-11-2021 on remote controllers used as an optional accessory with certain models of Ambulatory Insulin Infusion Pumps, manufactured by the medical devices company Medtronic, owing to cyber security risks which could have a serious impact on the patient.

The alert is related to the Medtronic MiniMed 508 pump and the 5xx and 7xx series Paradigm Pumps, which 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.

The Medical Device Alert issued by the CDSCO said 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.

An unauthorised person – someone other than a patient, patient caregiver, or healthcare provider – could potentially record and replay the wireless communication between the remote and the MiniMed insulin pump.

“Using specialised equipment, an unauthorised person could instruct the pump to either over-deliver insulin to a patient, leading to low blood sugar (hypoglycemia), or stop insulin deliver, leading to high blood sugar and diabetic ketoacidosis, even death,” it said.

The drug regulator, following intimation from the manufacturer, said any person who uses the remote controller feature with either the MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps may be affected.

The vulnerability is applicable to the MiniMed 508, MIniMed 511, MiniMed 512/712, MiniMed 515/715, MiniMed 522/722, MiniMed 523(K)/723(K), MiniMed 523/723 (Revel), MiniMed 554/754 (VEO), and MiniMed 551/751 (530G) pumps.

Healthcare providers and caregivers who treat people with diabetes who use remote controllers associated with either the MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps.

However, CDSCO has not received any complaints from the market on the issue, it added.

CDSCO, on October 11, raised the alert as the company recalled certain MiniMed 620G Insulin Pumps & Pump Kits and MiniMed 640G Insulin Pumps & Pump Kits after reported incidents of a loose reservoir that could no longer be locked into the pump, resulting in hypoglycemia and even death.

The company said that it is replacing any pump that has a clear retainer ring with one that has the updated black retainer ring at no charge.

In September, the drug regulator said that the company has also stopped distribution and sale of the HeartWare Ventricular Assist Device (HVAD), used to help the heart continue to pump blood to the rest of the body following reports of an increased risk of neurological adverse events and mortality associated with the pump.

USFDA has initiated a Class I recall, the most serious type of recall, in August, 2021, on the same product.

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