Device Problem
No Display/Image (1183)
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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 device 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 (blank screen) issue.The reporter alleged that the display screen was blank.There was no indication that the device caused or contributed to an adverse event.This complaint is being reported because the issue may result in an inability to use the product which may lead to long term cessation of delivery.
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Manufacturer Narrative
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Follow-up # 1 date of submission 2/19/2017.Device evaluation: the device has been returned and evaluated by product analysis on 1/27/2017 with the following findings:
during investigation, the display was fully functional, clear and legible.The display screen was not blank.The original complaint was unable to be duplicated.The pump was opened and there was no damage to the display flex connector.
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Search Alerts/Recalls
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