Device Problem
Retraction Problem (1536)
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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 motor (rewind issue) issue; rewind stops prior to completion at position 100-206.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the insulin delivery could be affected.
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Manufacturer Narrative
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Follow-up #1: date of submission 03/27/2017 device evaluation: the device has been returned and evaluated by product analysis on 03/06/2017 with the following findings: the pump was able to complete the rewind step successfully with no issues.The alleged issue could not be duplicated during the investigation.
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Search Alerts/Recalls
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