On (b)(6) 2018, the patient contacted animas and alleged that the time/date reverts to default time/date after a battery change.This issue is not likely to cause an adverse event without use error as the time and date must be verified before the patient uses the pump after a battery change.Apparently the patient recently checked the time/date and saw that the time was set to am when it should have been pm.At the same time, the patient stated that a blood glucose reading was 32 mg/dl with symptoms of dizziness and blurred vision.The patient said that treatment was ingestion of juice, with no assistance required.This complaint is being reported because the patient experienced hypoglycemia allegedly in response to the time settings being incorrect.Use error was a contributing factor as the patient did not correctly set the am/pm.
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