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.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.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.His is potentially reportable 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 device caused or contributed to an adverse event.
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Manufacturer Narrative
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Follow-up #1: date of submission 07/08/2016 device evaluation: the device has been returned and evaluated by product analysis on 06/24/2016 with the following findings: black box shows multiple eaw 128-fb80 alarms on multiple days.No battery cap or cartridge cap returned.All testing performed with test caps.Battery cap is able to fully tighten.Battery compartment intact.Pump case cracked adjacent to lower lh corner of keypad.During investigation a eaw 128-fe80 was received on each "rewind" attempt."idle and sleep" current draws within specifications.Removed pump case.Evidence of moisture damage inside pump on motor circuit and power circuit.Checklist fail due to internal moisture damage.
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Search Alerts/Recalls
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