More perspectives on insulin pump bubble problems.

1. From what I've read on forums about bubbles in insulin pump tubing, and from what I've heard from other pump-users with bubble troubles, physicians almost always say, "This is new to me. I haven't seen this problem before." A friend who's a relatively young physician said that physicians are almost obligated to say this. If they acknowledge they are aware there's a problem, then it can held to be their responsibility if something goes wrong and one of their patients is admitted to the hospital because of sky-high BG due to bubbles.

Also, it would be a LOT of work for a physician to go up against Medtronic, and few physicians would want to use their time fighting against large corporations. They want to follow their protocols; and they are less likely to be sued if they follow the conventional wisdom. And if nothing in the FDA approval literature says to watch out for bubbles, then bubbles don't exist.

2. From Medtronic's perspective, they're certainly going to deny there's a problem and blame bubbles on "patient error." Since we live in southern California, we offered to go to the Medtronic facility in the San Fernando Valley and discuss the situation with them. They said that would be fine with them, as long as we signed a nondisclosure agreement saying we would never ever divulge ANYTHING they told us, with the penalty for disclosure being major liability in a lawsuit. Needless to say, we haven't taken them up on their offer.

In a way, a bubble in the tubing is a perfect poison. There's no trace of it left after it goes into the body; and if someone ends up in the emergency room with high BG readings it's impossible to prove a bubble was the problem. The only way to prove bubbles cause problems is for a patient to deliberately allow a long (6" or longer) bubble to go through the tubing and into their body, take a video as the bubble moves, and then go to the emergency room with a BG higher than 500. In the emergency room, the patient, of course, would be likely to be referred to the psych ward for doing that to themselves.

"What about the FDA?" you ask. There is a system for reporting problems with medical devices and drugs. Here's the link:
https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
Lots of luck getting a meaningful response. The FDA is unlikely to get involved unless there's been real harm to a patient and, again, it's almost impossible to prove the harm was due to a bubble.

For now, all I know that people with bubble problems can do is to check their tubing 2-3 times a day, and prime out the bubbles before they reach the body. See my other postings for lots of detail.