Sometimes pump problems are deadly

FDA Finds Problems with Insulin Pumps

by James A. White WSJ Health Blog

All is not well in the land of insulin pumps — the devices that deliver insulin to mostly Type 1 diabetics — and the FDA wants to put a spotlight on the problem. Noting that there had been 18 recalls of pumps over five years because of hardware and software problems, the FDA said that “device problems critical to insulin pumps exist across manufacturers.” The agency has called a meeting of outside experts for Friday to see what can be done about the risks.

The FDA didn’t cite particular manufacturers, but insulin-pump makers include Johnson & Johnson, Medtronic and Roche Holding. See comments from those companies and other details from Reuters and Dow Jones Newswires.

People with Type 1 diabetes produce little or no insulin and increasing numbers are using insulin pumps to administer doses of the hormone. Defective pumps can allow blood sugar to rise too low or too high, which can be fatal.

Some 375,000 adults with Type 1 diabetes used pumps in 2007 and there were nearly 17,000 reports of health problems over the three years ended in 2009, according to the regulators. Makers are required to report problems potentially connected with devices to the FDA.

Such reports don’t mean there is necessarily something wrong with a device or that it caused harm, but FDA reviewers found many reports “have not been thoroughly investigated and evaluated by manufacturers in determining causality and device failure,” according to the FDA. Of 310 deaths examined, for example, it said “the device problem was unknown and limited details of the event were provided” in 225 of the death reports.

    Leave a Reply

    Fill in your details below or click an icon to log in: Logo

    You are commenting using your account. Log Out / Change )

    Twitter picture

    You are commenting using your Twitter account. Log Out / Change )

    Facebook photo

    You are commenting using your Facebook account. Log Out / Change )

    Google+ photo

    You are commenting using your Google+ account. Log Out / Change )

    Connecting to %s

%d bloggers like this: