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[IP] FW: Dislodged Infusion Cap on Paradigm
This is the response that I received from Mark Estes at MiniMed.
From: Mark Estes [mailto:email @ redacted]
Sent: Friday, June 14, 2002 11:50 AM
To: 'Grimes, Keith'
Subject: RE: Dislodged Infusion Cap on Paradigm
Your question: Has anyone experienced the problem described on DiabetesNet
dislodged infusion cap?
Answer, No. As the medical device manufacturer, we must track all product
complaints. We have never had a complaint on this issue on the paradigm.
It is a tempest in a teacup. It is not 'easy' to unscrew the reservoir.
There are 2 locking arms that provide a positive detent to locate the
reservoir. While the connector can be removed when you want it to, it is
very hard to remove by knocking it against anything. A knock of that
magnitude would be felt by the user. A knock of that magnitude would also
be likely to disconnect the connector on any other pump. Leur lock
connectors used on all other pumps also unscrew, don't give a warning when
unscrewed, and deliver insulin when tightened. Leur locks do not have the
locking tabs, they use friction to secure the connection. This is a tiny
issue and is not unique to the Paradigm. Were Diabetes net serving pumpers
instead of bashing MiniMed, they would point out the risks of all connectors
and would not have singled us out. Please note, there are many other false
and misleading statements about our products on the D-net site. We are not
clear on why our products are being attacked or that site's relations with
We do agree with one point in the d-net rant.
If one ever finds that the connector is out of position, they should
disconnect at the QR before tightening or reconnecting the cap. Such a
warning in is the training video and in the user guide. Here is the exact
Improper placement of the reservoir may result in inaccurate
delivery of insulin. Check to make sure the tubing connector
is locked onto the reservoir and the pump case
correctly, before connecting to the infusion set quick
If you have already connected the infusion set quick
release, disconnect BEFORE correcting the reservoir
Once the tubing connector is seated properly, do not partially
unscrew and re-tighten the tubing connector while the
infusion set is connected to your body.
From: Grimes, Keith [mailto:email @ redacted]
Sent: Friday, June 14, 2002 6:10 AM
To: 'email @ redacted'
Subject: Dislodged Infusion Cap on Paradigm
I sent the following message to the IP mailing list. I'm sending you a copy
as well to see what you have to say about this issue.
Another question from the guy still trying to choose between the R1000 and
Has anyone experienced the problem described on DiabetesNet regarding a
dislodged infusion cap? The problem is that if you dislodge the cap, you
will not receive any insulin - nor will you receive any warnings. So you
think you're getting that 7u bolus, but because the cap is dislodged, you're
not getting anything. Then, when you discover the cap is loose, if you
retighten it, you'll immediately get that 7u in a split second (and I'm
assuming you'll also receive any basals you missed as well). The infusion
cap does "lock" into place, but apparently it's not a true lock.
Now, is this just a tempest-in-a-teacup type of problem, or has anyone
actually experienced this? Should this make me really nervous, or do you
have to jump through all sorts of gyrations to dislodge this cap? I'd really
like to hear your experiences.
I did call MiniMed support regarding this issue. In a nutshell, her response
was that MiniMed's policy is if you experience two unexplained high BGs,
disconnect and change out the set. I'm not sure how to feel about this
I suppose, having never pumped before, that I could get in the habit of
always checking the tightness of the cap, but do I want to do this? Should I
have to do this?
Any responses are really appreciated.
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