Device Problem
Poor Quality Image (1408)
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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) 2015, the distributor contacted animas, alleging a display (dim/fading/color spectrum) issue.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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Manufacturer Narrative
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Follow-up #1: date of submission 12/18/2015 - device evaluation:
the pump has been returned and evaluated by product analysis on 12/05/2015 with the following findings: during investigation, the pump was powered on and the display was found to be discolored.Unrelated to the complaint, investigation revealed that the audio bolus button cover was torn.The audio bolus button responded appropriately during testing.
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Search Alerts/Recalls
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