UPDATE : Wednesday, August 5, 2020
Medtronic Korea denies regulatory negligence over recalled insulin pumps
  • By Kim Yun-mi
  • Published 2019.10.08 15:05
  • Updated 2019.10.08 15:05
  • comments 0

A group of diabetic patients criticized the local regulator for inadequate response to Medtronic insulin pumps recalled in the U.S., but its Korean unit flatly denied the accusation.

Before a parliamentary audit of the Ministry of Food and Drug Safety began on Monday, the civic group supporting diabetic patients said the ministry had not taken any measure on Medtronic’s insulin pumps recalled by the U.S. Food and Drug Administration. The group claimed that such inaction made local diabetic patients increasingly worried.

“The FDA has already put a notice since June to warn patients that Medtronic’s certain insulin pumps had potential cybersecurity risks. However, the food and drug safety ministry in Korea neither provided information on how to replace the problematic product nor sent a notification letter,” the group said in a statement.

The civic group also demanded the ministry identify all the local users of insulin pumps recalled in the U.S., replace the pumps with alternatives for patients, and send a notification letter to patients as soon as possible.

However, Medtronic Korea said the group’s allegations were not accurate.

“On June 17, we received a notice from our headquarters that the company would send a letter regarding insulin pumps’ vulnerability to potential cybersecurity risk. Our company reported this to the food and drug safety ministry via its electronic report center on June 19 for the first time,” Medtronic Korea said.

According to Medtronic Korea, locally distributed insulin pumps among recalled products were MiniMed Paradigm Insulin Pump MMT-712, MMT-522, and MMT-722WWS.

“We sent the safety letter concerning these products because the U.S. enhanced security requirements for cybersecurity issues. In America, we have consulted with the FDA and other authorities to ensure that all medical personnel and patients who use these products receive the notice,” the company said. “In Korea, we also sent the letter to all patients and healthcare professionals using these products in June.”

The Korean unit sent the medical device safety letter to users on June 28 via mail and finally reported to the food and drug safety ministry through the “Report of Sending Notification Letter for Medical Device Use” on Aug. 2.

Medtronic Korea said there had been no reported cases of cybersecurity problems caused by the recalled insulin pumps locally or internationally. Replacement of the recalled insulin pumps is possible through consultations with the doctor and the patient. Still, patients do not need to replace their insulin pumps just because of the recall, the company added.

“A recall by the FDA refers to all types of on-site corrective actions for patients’ health and safety, including sharing information with patients and medical staff through safety letters. It also includes preemptive and preventive responses to rule out potential possibilities that may affect patients’ health,” Medtronic Korea said. “Medtronic puts patients’ health and safety as a top priority and is ready to respond actively to inquiries.”

However, the company said the civic group did not make any inquiries about the recall issue.


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