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 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.(b)(6).
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Event Description
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On (b)(6) 2016, the reporter contacted animas, alleging a power (battery life) issue.There was no indication that the product caused or contributed to an adverse event.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.
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Manufacturer Narrative
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Follow-up #1 date of submission 08/02/2016-device evaluation: the pump has been returned and evaluated by product analysis on 07/11/2016 with the following findings: a review of the pump black box data indicated no related alarms and no evidence of short battery life.During a visual inspection of the pump, the battery compartment was observed to be intact with no damage or evidence of moisture ingress.The battery cap secured properly to the pump, and a power loss was not observed.Current draws measured within specifications.The pump case was removed and no evidence of moisture ingress or loose components was found to printed circuit board.Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release.(b)(4).
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Search Alerts/Recalls
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