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
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) 2016, the reporter contacted animas, alleging that there was an intermittent power 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 09/19/2016 device evaluation: the device has been returned and evaluated by product analysis on 08/25/2016 with the following findings: the pump's black box showed multiple unexpected pump reboot events on 07/11/2016.The battery compartment was cracked on the side from the threads down to the case seal.The returned battery cap was able to fit to maintain an electrical connection.The battery cap was fastened and the unscrewed a half turn with no reboots occurring.The ¿ez-prime¿ steps were performed correctly with no power interruptions occurring during the investigation.The alleged issue could not be duplicated.
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Search Alerts/Recalls
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