Device Problem
Device Stops Intermittently (1599)
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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 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 power (intermittent power) 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 09/07/2016 device evaluation:
the pump has been returned and evaluated by product analysis on 08/10/2016 with the following findings: a review of the black box data showed no expected reboots.The returned battery cap was undamaged and was able to attach on to the pump.The pump powered on normally with the returned battery cap.The battery cap was tightened then loosened one half turn and no power issue occurred.The pump cover was opened and moisture damage was found on the continuous glucose monitor and power printed circuit board.
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Search Alerts/Recalls
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