Device Problem
Battery Problem (2885)
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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 (battery life) issue.This complaint is being reported as the issue may result in a long term cessation of insulin delivery if the user is unable to resolve the alarm.There was no indication that the product caused or contributed to an adverse event.
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Manufacturer Narrative
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Device evaluation: the device has been returned and evaluated by product analysis on 08/05/2016 with the following findings: frequent low battery warnings were observed.Short battery life was observed in the black box data.The pump electrical current draws were high.When the cgm (continuous glucose monitoring) board was disconnected from the pump, the current draws returned to normal.No damages were found to the cgm board.
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Search Alerts/Recalls
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