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 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.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 01/26/2017.Device evaluation: the device has been returned and evaluated by product analysis on 01/09/2017 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.Unrelated to the original complaint, the battery compartment was noted to be cracked.
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Search Alerts/Recalls
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