The pump has not been returned to animas for evaluation.If the device is returned, an evaluation shall be completed and a supplemental report will be filed.No conclusions can be made at this time.Follow-up # 1 date of submission 03/23/2015 ¿ device evaluation: the pump has been returned and evaluated by product analysis on 03/11/2015 with the following findings: during testing, the display was found to be faded and discolored.Initial reporter: (b)(6).
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On (b)(6) 2015, the reporter contacted animas, alleging a display (dim/fading/color spectrum) issue.The distributor alleged that the display screen was discolored.This complaint is being reported because the reported issue was not resolved with troubleshooting.There was no indication that the product caused or contributed to an adverse event.
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