On (b)(6) 2016 the reporter contacted animas alleging that on an unspecified date, the patient experienced elevated blood glucose (bg) of "high" (>600mg/dl) with no reported signs or symptoms of hyperglycemia.Reportedly, the patient did not receive any treatment above and beyond the usual routine of diabetes care and management and discontinued insulin pump therapy.The reporter noted that the pump's motor was making a grinding noise and was loud during the rewind and prime steps.The reporter stated that they felt the issue was impacting insulin delivery.This complaint is being reported based on the allegation that the patient experienced hyperglycemia associated with a motor issue.
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Follow-up #1: date of submission 07/28/2016.Device evaluation: the device has been returned and evaluated by product analysis on 07/07/2016 with the following findings:
a review of the pump histories did not find any errors, alarms, or warnings associated with the complaint.A review of the total daily dose history indicated that insulin delivery totals correctly reflected programmed values.Multiple rewind, load, and prime steps were performed successfully with no motor noises occurring.The pump was exercised for 24 hours with no issues occurring.The pump passed delivery accuracy testing and was found to be delivering within required specifications.The pump cover was removed and no internal defects were found.The complaint could not be confirmed or duplicated on investigation.
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