Customer reported via phone call that they experienced high blood glucose level of 480 mg/dl.The customer had symptoms such as difficulty breathing, heart racing, and vision issues and treated with manual insulin injection.Customer's blood glucose value was 428 mg/dl at the time of the call.Customer reported that the high blood glucose levels began on (b)(6) 2017.Troubleshooting was performed.The drive support cap appeared normal.There were no leaks or air bubbles.There were no site or insulin issues.The device settings were correct.Customer was advised to change the infusion set, reservoir and insulin and to treat per healthcare professional's recommendation.The product was not returned for analysis.
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