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There may be an intermittent loss of contact between the battery cap and the battery compartment in the pump which may result in the device resetting. This can cause the device to stop administering insulin, which could result in an excess level of glucose in the blood (hyperglycemia). Additionally, this failure may lead to user confusion in the amount of insulin administered, contributing to errors in future doses, which may result in lower than normal level of glucose in the blood (hypoglycemia). Healthcare professionals are advised to ensure that their patients replace the battery cap on their insulin pump.
Read the complete MedWatch 2008 Safety summary, including a link to the Class 1 Recall Notice, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#batterycap
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