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 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.
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Event Description
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On (b)(6) 2016, the reporter contacted animas, alleging a display (blank screen) issue.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.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 01/09/2017.Device evaluation:
the device has been returned and evaluated by product analysis on 12/15/2016 with the following findings: during investigation, the pump was powered on with auditory and vibration function, however, the display screen was blank.The pump case was opened and an unidentified intermittent condition on the printed circuit board was determined to be the cause of the blank display.
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Search Alerts/Recalls
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