The tandem pump user guide states, "make sure that you always have an insulin syringe and vial of insulin or a prefilled insulin pen with you as a backup for emergency situations." the device has been received for evaluation; however, device evaluation is not yet complete.A supplemental report will be filed upon completion of the evaluation.
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It was reported that a continuous glucose monitor (cgm) error 41 occurred on 6/7/2020.Two days later the customer went to the emergency room and was subsequently hospitalized due to an elevated blood glucose (bg) level, high blood pressure, and chest pain; (specific bg value was not provided).Customer had continued to use the pump without an active cgm for insulin therapy and as a result did not adequately manage diabetes properly.A magnetic resonance imaging and a computerized axial tomography scan was performed on the customer, and was treated with intravenous fluids and insulin injections.Treatment received resolved the reported issue, and the customer was released from the hospital on (b)(6) 2020 with no permanent damage.
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