Device Problems
No Display/Image (1183); Moisture Damage (1405)
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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 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 that the display screen was blank and moisture was present.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 08/09/2016 device evaluation: the device has been returned and evaluated by product analysis on 07/18/2016 with the following findings: there was visible moisture on the display screen.The display was blank when the pump was powered on.Moisture was found on the internal componetns of the pump.
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Search Alerts/Recalls
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