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 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 temperature (temp - no physical damage) issue.This complaint is being reported because there is the potential for the user to experience an injury to the skin due to increased pump temperature.There was no indication that the product caused or contributed to an adverse event.
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Manufacturer Narrative
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The device has been returned and evaluated by product analysis on 12/29/2016 with the following findings: a review of the black box showed no unusual voltage fluctuation.The battery compartment and cap were undamaged and were able to fit securely.The prime, rewind, and load steps were performed correctly.All current readings were within specification.No overheating occurred during the investigation.The pump cover was removed to find no intermittent conditions to the printed circuit board.The temperature complaint was unable to be duplicated.
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Search Alerts/Recalls
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