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 been returned to animas.Evaluation has not yet been completed.When evaluation is complete a supplemental report will be filed.No conclusion 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 a display (dim/fading/color spectrum) issue.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 08/26/2016.Device evaluation: the device has been returned and evaluated by product analysis on 08/09/2016 with the following findings:
during investigation, the pump powered on to a dim and discolored display.Unrelated to the original complaint, the battery compartment was noted to be cracked in two places.
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Search Alerts/Recalls
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