Deep Flaws in FDA Oversight of Medical Devices, and Patient Harm, Exposed in Lawsuits and Records

(By Fred Schulte and Holly K. Hacker for KFF Health News)

Living with diabetes, Carlton “PeeWee” Gautney Jr. relied on a digital device about the size of a deck of playing cards to pump insulin into his bloodstream.

The pump, manufactured by device maker Medtronic, connected plastic tubing to an insulin reservoir, which Gautney set to release doses of the vital hormone over the course of the day. Gautney, a motorcycle enthusiast, worked as a dispatcher with the police department in Opp, Alabama.

The 59-year-old died suddenly on May 17, 2020, because — his family believes — the pump malfunctioned and delivered a fatal overdose of insulin. Continue reading here…

Kaiser Health News is a nonprofit national health policy news service that is part of the nonpartisan Henry J Kaiser Family Foundation.

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