On (b)(6) 2016 it was reported that the patient's blood glucose was 184mg/dl with no signs or symptoms of hyperglycemia after taking a dose of insulin from the device.There was no medical intervention; the patient replaced the device with a new one, dosed with insulin, and hyperglycemia resolved.This hyperglycemic incident does not meet the definition of an adverse event.It was said that when the patient removed the device from the skin, the cannula was bent.This complaint is being reported because the device was unable to deliver insulin due to a bent cannula.
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