Device Problem
Temperature Problem (3022)
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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 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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Follow-up #1: date of submission 06/23/2016.Device evaluation: the device has been returned and evaluated by product analysis on 06/10/2016 with the following findings: product evaluation was conducted and the alleged complaint could not be verified or duplicated.The review of the black box data did not show any temperature related activity in the pump history.No damages were observed to the battery compartment or the cap.Additionally, no overheating was duplicated during the actual pump testing.The pump electrical current draws measured within specification.The pump case was opened up and no damages or any evidence of internal moisture were observed.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.
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Search Alerts/Recalls
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