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[IP] Waterproof Letter to D--some additional facts
Ok. I can't keep silent anymore. I am one of the 7 to 10 people who has
reported the malfunction that Disetronic has finally responded to. After
seeing the admirable letter that several of you have worked so hard on, I
feel the need to clear up some assumptions you may have about the
Almost everything I am about to say is public, and can be received through
the Food and Drug Administration's MAUDE database. (See address below.)
Although I am extremely happy that Disetronic sent the letter to consumers
warning us against using the pump in water, I realize that the letter never
explained what actually happened to people who experienced the malfunction.
This lack of explanation has raised many questions on this list serve about
how pump-wearers could have received an overinfusion while wearing the pump
in water. What Disetronic didn't explain is that it appears that when water
reaches some portion of the pump, it shorts and, rather than shutting down,
goes into "go" mode and releases ALL of the insulin in the cartridge,
assuming the batteries don't run out first. Needless to say, this can be
My pump malfunctioned while I was snorkeling in Hawaii. I had worn the pump
for about 6 months and had never taken it into water. I am extremely
cautious and even called Disetronic before snorkeling with it to make sure
it was really safe. I was told there would be no problem. It turns out
that there was a hairline crack between the H and M buttons, water got in,
and the pump went into "runaway" mode, overinfusing me with 200 units of
insulin (8 days-worth for me).
You can go to the MAUDE database and read all the gory details (put in
"snorkeling" and "Hawaii"), but suffice it to say I am lucky to be alive. I
was fortunate enough to get out of the water and discover what happened in
time to consume several hundred grams of fast-acting carbs I happened to
have in my hotel room (having just run a marathon the previous day). Even
then, I had to be rushed to the hospital by ambulance and hooked up to
glucose IVs off and on for the next 13 hours.
I believe this information is particularly pertinent to those who think--as
the letter drafted to Disetronic states--that you can continue to wear the
pump in water, and "keep materials on hand to deal with any hypoglycemic
event." Unless you carry lots of IV glucose with you (and know how to
insert it) and catch it in time, this response is unrealistic. It might be
that Disetronic is now refusing to guaranteee the machine as waterproof
because it doesn't want to replace damaged pumps. It might also be that it
does not want to have to defend against a wrongful death suit.
You should know that this malfunction has occurred over the years, with the
HTRON as well as the HTRON plus. It happened to at least 3 people other
than myself just last summer. Whether there is a "bad batch" out there or
an overall design defect has yet to be determined. I only know that, had I
known about this possibility--as Disetronic certainly did--before it
happened to me, I would have NEVER have taken it into the water.
Each of you will have to make your own decision about whether to wear the
pump in water. But I have decided that I would not be able to live with
myself if I continued to watch this discussion and, due to the downplaying
of the incidents, another person was injured. The realization that I had
just been infused with 8 days of insulin was the most frightening experience
of my life, and I would not wish it on anyone.
If you would like to look at FDA reports detailing my and other incidents,
you may find them at:
"Hypoglycemia" and "water" are good search words, although they won't catch
all the incidents.
Sign the letter that has been drafted if you like. I am sure that
Disetronic representatives monitor this site and have already seen it. But
be aware of the potential dangers if you choose to (continue to) wear your
pump in water.
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