On (b)(6) 2016, the reporter contacted animas, alleging a history/settings (inaccurate delivery) issue.No further information was provided.This complaint is being reported because the reported issue remained unresolved.There was no indication that the product caused or contributed to an adverse event.
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Follow-up #1: date of submission 03/29/2016 device evaluation: the device has been returned and evaluated by product analysis on 03/14/2016 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 pump histories indicated that the last recorded bolus delivery was a 1.15unit bolus on (b)(6) 2015 and the last basal delivery was on (b)(6) 2015.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 delivery interruptions or errors, alarms, or warnings occurred during investigation.Test boluses were performed successfully and accurately recorded in the pump histories.Unrelated to the original complaint, investigation revealed that the display was discolored and the battery compartment was cracked in two places.
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