Investigation revealed that customer was most likely using sensor glucose value for blood glucose meter calibration.This is not the intended use of the device.User self-treated with a dose of insulin during the hyperglycemia event.However, user was eventually hospitalized for diabetic ketoacidosis and user was treated at the hospital and recovered.D8 updated,was this device serviced by a third party? no health effect - clinical code updated to 1905 and 2364 health effect -impact code updated to 4614 medical device problem code updated to 1307 component code updated to 3141 type of investigation updated to 4111 and 4114 investigation findings updated to 114 investigation conclusions updated to 19.
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