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 been returned to animas.Evaluation has not yet been completed.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 audio tone/vibration (intermittent sound) 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 04/22/2016 - device evaluation:
the pump has been returned and evaluated by product analysis on 04/07/2016 with the following findings: during investigation, the pump powered on with no auditory sounds upon start up.The pump¿s cover was removed and the piezo spring contacts were found to be misaligned; after a realignment of the piezo spring contacts, the auditory feature functioned properly.The complaint of a ¿chirp alarm¿ was not duplicated during investigation.
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Search Alerts/Recalls
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