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[IP] RECALL Disetronic Medical Systems Inc. ACCU-CHEKŪ Spirit insulin pump



http://www.fda.gov/oc/po/firmrecalls/disetronic04_09.html
FOR IMMEDIATE RELEASE -- April 30, 2009 -- This notification applies to all
ACCU-CHEK. Spirit insulin pumps with serial numbers from SN02119552 through
SN10006093 (range of SN shipped to the US). Pumps with serial numbers
including and above SN10006094 are not affected and no action is required by
users of these pumps.

Disetronic Medical Systems Inc. announced today that it is notifying its
customers, distributors and healthcare professionals about a potential
defect in the up and/or down buttons of some ACCU-CHEK Spirit insulin
pumps.  This failure may present as an intermittent or complete loss of
function of the up and/or down buttons.  The pumps up and down
buttons are used for changing the program in the menu or to administer
additional insulin through a bolus delivery.  If the buttons do not
function, users may not be able to change any programmed setting on the
pump.  If this failure occurs, the pump may not respond with a vibration or
acoustic confirmation signal to a button press and the display will remain
unchanged. This defect was discovered through the companys normal quality
control monitoring process.
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SEE LINK at top of page

John S Wilkinson
Rome, NY
.
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