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Re: [IP] Fwd: Disetronic and the waterproofness -- Judy

In a message dated 3/22/01 11:42:40 AM, email @ redacted writes:

<< http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm

enter LZG in the Product Code box and the dates 08/01/2000 to 08/15/2000.

You'll find the only reported incident of this, I believe it happened

sometime around August 6, 2000.  Btw, if anyone would like to look at

reports of all reported pump problems you can search this site, >>

Roselea, I have logged on to this site several times in the last 2-3 years, 
and it has been bothering me, so maybe this is the time to bring it up.  The 
incidents reported here have been reported to Medwatch.  This reporting is 
required of medical facilities in the case of death or serious injury.  (And 
I guess even a death or serious injury needn't be recorded if not in a 
medical facility).  All other reports are voluntary, and they are a 
hodgepodge, from nurses seeing a pump and assuming that is the problem to 
user error to occasional reported (and sometimes questionable) equipment 
failure.  I have never seen reported any of the pump problem incidents 
individuals have reported to this list.  (I have seen a couple other reports 
of D pumps emptying their reservoirs in water -- one I just found was in 97). 
 I have actually been planning to talk to someone at CDRH about making the 
system more useful -- it seems to me that in the case of insulin pumps, user 
input may be more useful than in most cases.  Anyway, medical device problems 
can be reported on-line to MEDWATCH, but not having tried it I can't assure 
you that such reports would be put into the list (they say something about 
preferring to have medical personnel do it, but that consumers are allowed to 
if they don't feel comfortable asking the doctor.)

Linda Z
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