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 but 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.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 08/25/2016 device evaluation: the device has been returned and evaluated by product analysis on 08/03/2016 with the following findings: the display was found to be dim and pink.Unrelated to the complaint, the battery compartment was found to be cracked below the grip pad.
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Search Alerts/Recalls
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