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 hast been returned to animas for evaluation.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 reporter 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 09/10/2015-device evaluation: the pump has been returned and evaluated by product analysis on (b)(4) 2015 with the following findings: during investigation, the pump was powered on and revealed a dim, discolored display.
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Search Alerts/Recalls
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