Device Problem
Temperature Problem (3022)
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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 temperature (temp - no physical damage) issue.There was no indication that the product caused or contributed to an adverse event.This issue is being reported because there is the potential for the user to experience an injury to the skin due to increased pump temperature.
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Manufacturer Narrative
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Follow-up #1: date of submission 03/30/2017 device evaluation: the device has been returned and evaluated by product analysis on 03/08/2017 with the following findings: a review of the black box showed no activity related to the temperature complaint.The rewind, load, and prime steps were performed successfully.No overheating occurred during testing.The pump electrical current draws were found within specification.The pump was opened to find no damage or evidence of internal moisture.
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Search Alerts/Recalls
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