Device Problem
Material Discolored (1170)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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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.(b)(6).
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Event Description
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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 reportable 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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Manufacturer Narrative
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Follow-up #1: date of submission 10/10/2106 device evaluation: the device has been returned and evaluated by product analysis on 09/16/2016 with the following findings: the display was dim, faded and pink.
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Search Alerts/Recalls
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