On (b)(6) 2016, the reporter contacted animas, alleging a motor (rewind issue) issue.It was alleged that the piston rod was not retracting.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the reported issue was not resolved with troubleshooting.
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The device has been returned and evaluated by product analysis on 02/23/2017 with the following findings: a review of the black box showed no rewind motor errors recorded in the black box history.The rewind, load, and prime steps were performed successfully.The pump was run for 24 hours and no motor issues occurred.The original complaint of a motor issue was not able to be duplicated.Unrelated to the original complaint, the battery compartment was cracked to the bumper pad.Additionally, the display was dim with a red hue.
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