Per tandem's user guide: do not deliver a bolus until you have reviewed the calculated bolus amount on the pump display.If you dose an insulin amount that is too high or too low, this could cause very high or very low blood glucose.You can always adjust the insulin units up or down before you decide to deliver your bolus.No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.
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It was reported that the customer delivered the incorrect insulin amount via a bolus.The customer's blood glucose (bg) level was 58 mg/dl.Subsequently, customer was hospitalized.Bg was treated with intravenous fluids, and unspecified intravenous treatment.The customer was still hospitalized at the time of the call with tandem technical support.The customer subsequently suffered a heart attack.Multiple follow up attempts were made by tandem technical support, however, no response received.
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