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Drugs & Medical Devices

Will Medtronic’s MiniMed 640 Pump Glitch affect its PMA Status?

— July 29, 2015


The MiniMed 640 Photo courtesy of Medtronic/Fierce Medical Devices
The MiniMed 640
Photo courtesy of Medtronic/Fierce Medical Devices

Minnesota-based device giant Medtronic has issued letters to nearly 2,000 owners of the MiniMed 640 and 620 insulin pumps in Europe, warning them of a potential glitch in the reading mechanism. According to the letter, there is an error with the Bolus Wizard screen, causing it to not time-out and instead giving an outdated reading. The Food and Drug Administration (FDA) issued a Class II recall in a notice released on July 24th, which indicates it “can cause reversible adverse health consequences.” Medtronic is instructing users to not activate glucose delivery based on bolus readings that are older than 12 minutes. The company does not want users to return the devices; instead it is sending customers an updated user’s guide to inform them to be aware of the glitch, including a summary of the malfunction. The FDA warns that the erroneous reading “could cause confusion by showing a bolus amount that is no longer appropriate.”

A company spokesperson told MassDevice, “We thank our customers for continuing to put their trust in us and encourage anyone with questions to contact their healthcare professional.” In total, the recall affects 1,936 MiniMed owners in Australia, the Czech Republic, Denmark, Finland, France, Ireland, Netherlands, Norway, Sweden, and the United Kingdom. According to the FDA notice, the cause of the defect has yet to be determined; however the agency is investigating the issue. The MiniMed 640 has only recently been introduced to Europe in January, and Medtronic has scheduled a Pre-Market Approval (PMA) submission in the U.S. later this year. It is unknown whether or not the FDA will require a permanent solution to the glitch in order to gain PMA for use in U.S. markets.

The MiniMed 640G is thought to be a major breakthrough in diabetes care. The pump uses Medtronic’s “SmartGuard” technology, which is supposed to automatically monitor glucose readings and deliver insulin based on optimal glucose levels. It is considered to be a major step toward the invention of an artificial pancreas, which would be able to essentially automate diabetes care for many patients. Medtronic has used European markets more frequently in a push to expand its role in diabetes care. With $467 million in revenues involving diabetes care, it makes up a small, but high profit sector of Medtronic’s $7.3 billion overall revenue. In recent months, the company has partnered with the diabetes sectors of IBM’s Watson Health, and diabetes data management company, Glooko. It also acquired diabetes services company, Diabeter, in April.



Fierce Medical Devices – Stacy Lawrence

Food and Drug Administration

Mass Device – Fink Densford



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