Currently, it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We, therefore, consider this report complete to the best of our knowledge.
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The customer's mother reported via phone call of issues with customer's high blood glucose levels.The customer's blood glucose level was reported to be 600mg/dl.The mother states there was an incident where the device delivered only 1 unit of insulin and shows having delivered 13 units on previous occasions.The mother states there were no alarms.The mother states they treated with the help of their healthcare provider.The mother states they adjusted the vassal rate and changed out the set.The mother refused to troubleshoot for the highs.The mother also states of incident where meter was reading 75mg/dl, and the sensor was reading 58mg/dl.The caller states there were no low alerts.The pump was not present at the time, so troubleshoot could not be conducted.The mother was advised to call back when pump is available, in order to troubleshoot.
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