Device Problem
Device Stops Intermittently (1599)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
No Answer Provided
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Manufacturer Narrative
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The pump has not been returned to animas.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 an intermittent power issue with the pump.There is no additional information available for this complaint.There was no reported adverse event associated with this complaint.This complaint is reportable because the user may be unaware that the pump has lost power, leading to under delivery.
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Manufacturer Narrative
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Follow-up #1: date of submission 10/07/2016 device evaluation: the device has been returned and evaluated by product analysis on 09/20/2016 with the following findings: a review of the black box revealed unexpected power on reset (por) events on (b)(6) 2016.The battery compartment was observed to be cracked below the grip pad.There was no damage found to the returned battery cap; the battery cap secured tightly to the pump.The battery cap contact height and width measurements were within specification.During testing, the battery cap was fastened and then unscrewed ½ turn with no reboots occurring.The ¿ez-prime¿ steps were performed correctly with no power interruptions or any errors, alarms or warnings.The pump¿s cover was removed with no intermittent conditions found to the power circuit.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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