On (b)(6) 2016, the reporter contacted animas, alleging a display (dim/fading/color spectrum) issue.There was no indication that the product caused or contributed to an adverse event.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.
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Device evaluation: the pump has been returned and evaluated by product analysis on 08/04/2016 with the following findings: during investigation, the pump was powered on and the display was found to be dim, faded and discolored.Unrelated to the complaint, investigation revealed multiple cracks in the battery compartment.Also unrelated to the display issue, a crack in the pump case was observed between the case seal and keypad.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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