On (b)(6) 2016, the reporter contacted animas, alleging a prime (unable to prime) issue.This complaint is being reported because the issue may result in a long term cessation of insulin delivery if the user is unable to resolve the alarm.There was no indication that the product caused or contributed to an adverse event.
|
Follow-up #1: date of submission 02/15/2017.The device has been returned and evaluated by product analysis on 01/31/2017 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.The pump successfully completed a rewind, load, and prime sequence.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.No defects were found on investigation; the complaint could not be confirmed or duplicated.
|