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 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: 03/28/2017.Device evaluation: the device has been returned and evaluated by product analysis on 03/08/2017 with the following findings: the black box showed usual fluctuation of voltage resulting in replace battery alarms.The pump current draws measured within specification.A "battery life" issue was not duplicated during testing.There was no moisture or corrosion observed in the battery compartment and no damage found to the returned battery cap.The cap was able to fully tighten to the pump and power it on.Unrelated to the original complaint, the battery compartment was cracked and the display was discolored.The pump cover was removed and evidence of moisture was found on the transceiver 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.
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Search Alerts/Recalls
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