Follow-up #1: date of submission 04/26/2016 device evaluation: the device has been returned and evaluated by product analysis on (b)(4) 2016 with the following findings: a review of the black box indicated a drastic voltage drop that led to the pump getting warm on (b)(6) 2016.No activity outside normal use was found in the pump histories for (b)(6) 2016.Visual inspection did not find any damage to the battery compartment or cap.The pump powered on normally and successfully completed rewind, load, and prime steps.All current draws were within specifications during investigation; no overheating occurred.The pump cover was removed and no internal defects were found.The complaint could not be duplicated on investigation.Unrelated to the complaint, investigation revealed that the display was dim and discolored.Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release.
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