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.This report is made under the requirements of the medical device reporting regulations and does not constitute an admission on the part of animas of any deficiency in the performance of the device.Follow-up # 1 date of submission 03/27/2015.Device evaluation: the pump has been returned and evaluated by product analysis on 03/16/2015 with the following findings: during testing, the display was found to be dim and discolored.This report is made under the requirements of the medical device reporting regulations and does not constitute an admission on the part of animas of any deficiency in the performance of the device.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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