Insulin Pump Bug - DAFNE Online

August 05, 2013 07:54

Yorky DAFNE Graduate
Hertfordshire Community NHS Trust 1 post

G'day All,
As an IT geek, I know the possibility of "bugs" in software is always present (especially as I get paid to find them!) The article below is from a security website:

http://www.scmagazine.com.au/News/352073,diabetic-researcher-finds-insulin-pump-memory-glitch-that-almost-killed-him.aspx?eid=7&edate=20130805&utm_source=20130805&utm_medium=newsletter&utm_campaign=daily_newsletter

The big concern is this type of bug should have been tested for, as changing batteries is a basic user function of the device.

I guess the moral of the story is check, double-check, and just to be safe, check again. We all put our faith in devices (pumps/ BG monitors) - and we all assume they're working fine. How often do we all check our BG monitor is actually reading correctly with control liquid? Your devices may not ever experience a problem, but that doesn't mean it will never happen...

August 06, 2013 19:47

marke Site Administrator
South East Kent PCT 681 posts

Yes, but the article does not provide any details of what actually happened, it sensationalises the issue without providing any real details. All medical devices do go through a lot of testing and its hard to believe as you say they did not test for this, Without all the facts its easy to look at the worst case scenario. As
you say having an kind of technology doesn't move the responsibility away from the user to ensure correct operation. The article says HE mistakenly infused himself with the wrong dose, unless it gave a completely wrong BG reading why did he do this ? It makes no mention of this.

August 07, 2013 10:37

davidcragg DAFNE Graduate
Sheffield Teaching Hospitals 17 posts

For a slightly more measured article on the issue, see http://www.bloomberg.com/news/2013-07-22/medical-device-hackers-find-government-ally-to-pressure-industry.html

In his complaint to the FDA, Radcliffe claims his Animas pump inaccurately calculates the amount of insulin to dispense after the battery is changed. The pump does not automatically factor in the amount of insulin it dispensed immediately before the battery was removed, he said.

That issue led to dosing errors that caused him to experience two low-blood-sugar episodes, which can be fatal, Radcliffe said.

The pump is designed to reset insulin levels following a battery change, said Brian Levy, medical director at Animas. The patient's insulin history is still stored on the device, and instructions for recalibrating the machine are in the owner's manual, he said. The company does not plan to make any changes.

Radcliffe said he's unsatisfied with the response and intends to push the company in public and private to fix the issue.

Essentially it seems Radcliffe didn't follow the manufactures instructions correctly and thinks the user shouldn't have to do the recalibration step after changing the batteries.

So in this case I would say it was more a case of user error than equipment malfunction, however I agree with you that checking your diabetes equipment is an important aspect to consider.

August 07, 2013 11:36

JayBee DAFNE Graduate
James Paget University Hospitals NHS Foundation Trust 587 posts

You generally find you have to do the same for your blood testing kit too... What a silly (could even say lazy) person. :/

Stay safe y'all.

August 05, 2013 07:54 Yorky DAFNE Graduate Hertfordshire Community NHS Trust 1 post	G'day All, As an IT geek, I know the possibility of "bugs" in software is always present (especially as I get paid to find them!) The article below is from a security website: http://www.scmagazine.com.au/News/352073,diabetic-researcher-finds-insulin-pump-memory-glitch-that-almost-killed-him.aspx?eid=7&edate=20130805&utm_source=20130805&utm_medium=newsletter&utm_campaign=daily_newsletter The big concern is this type of bug should have been tested for, as changing batteries is a basic user function of the device. I guess the moral of the story is check, double-check, and just to be safe, check again. We all put our faith in devices (pumps/ BG monitors) - and we all assume they're working fine. How often do we all check our BG monitor is actually reading correctly with control liquid? Your devices may not ever experience a problem, but that doesn't mean it will never happen...
August 06, 2013 19:47 marke Site Administrator South East Kent PCT 681 posts	Yes, but the article does not provide any details of what actually happened, it sensationalises the issue without providing any real details. All medical devices do go through a lot of testing and its hard to believe as you say they did not test for this, Without all the facts its easy to look at the worst case scenario. As you say having an kind of technology doesn't move the responsibility away from the user to ensure correct operation. The article says HE mistakenly infused himself with the wrong dose, unless it gave a completely wrong BG reading why did he do this ? It makes no mention of this.
August 07, 2013 10:37 davidcragg DAFNE Graduate Sheffield Teaching Hospitals 17 posts	For a slightly more measured article on the issue, see http://www.bloomberg.com/news/2013-07-22/medical-device-hackers-find-government-ally-to-pressure-industry.html In his complaint to the FDA, Radcliffe claims his Animas pump inaccurately calculates the amount of insulin to dispense after the battery is changed. The pump does not automatically factor in the amount of insulin it dispensed immediately before the battery was removed, he said. That issue led to dosing errors that caused him to experience two low-blood-sugar episodes, which can be fatal, Radcliffe said. The pump is designed to reset insulin levels following a battery change, said Brian Levy, medical director at Animas. The patient's insulin history is still stored on the device, and instructions for recalibrating the machine are in the owner's manual, he said. The company does not plan to make any changes. Radcliffe said he's unsatisfied with the response and intends to push the company in public and private to fix the issue. Essentially it seems Radcliffe didn't follow the manufactures instructions correctly and thinks the user shouldn't have to do the recalibration step after changing the batteries. So in this case I would say it was more a case of user error than equipment malfunction, however I agree with you that checking your diabetes equipment is an important aspect to consider.
August 07, 2013 11:36 JayBee DAFNE Graduate James Paget University Hospitals NHS Foundation Trust 587 posts	You generally find you have to do the same for your blood testing kit too... What a silly (could even say lazy) person. :/ Stay safe y'all.