Device Problem
Premature Discharge of Battery (1057)
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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) 2017, the reporter contacted animas, alleging a power (battery life) issue.This complaint is being reported because 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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Follow-up #1: date of submission 03/28/2017.Device evaluation: the device has been returned and evaluated by product analysis on 03/08/2017 with the following findings: there were frequent replace battery alarms observed in the pump history.The pump's electrical current draws were tested and were within specifications.The battery compartment was cracked above and below the bumper pad.Corrosion was found in the battery compartment.
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Search Alerts/Recalls
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