Device Problem
Image Display Error/Artifact (1304)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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The pump has been returned to animas but not yet evaluated.When the evaluation is complete, a supplemental report will be filed.No conclusions can be made at this time.
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Event Description
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On (b)(6) 2016, the reporter contacted animas, alleging that the display screen was dim and discolored.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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Manufacturer Narrative
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Follow-up #1: date of submission 03/07/2017.Device evaluation: the device has been returned and evaluated by product analysis on 02/17/2017 with the following findings: on investigation, the pump powered on and the display became illuminated per normal operation.The display screen was examined and confirmed to be dim/faded and discolored.
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Search Alerts/Recalls
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