On (b)(6) 2016, the reporter contacted animas, alleging a display (dim/fading/color spectrum) issue.This complaint is being reported because the issue may impact the user's ability to read some or all of the information on the screen which may result in over or under delivery.There was no indication that the product caused or contributed to an adverse event.
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The device has been returned and evaluated by product analysis on 02/07/2017 with the following findings: during testing, the pump was powered on and the display screen appeared dim and discolored.The complaint was duplicated.Unrelated to the complaint, the battery compartment was observed to be cracked in two places.Additionally, the bolus button cover was observed to be torn; however, the button responded properly to user presses.
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