Follow-up #1: date of submission 07/14/2016.Device evaluation: the device has been returned and evaluated by product analysis on 06/23/2016 with the following findings: the review of the black box showed recurring power reboots.Investigators were able to duplicate the intermittent power issue during the battery cap functional test; however, investigators were able to successfully run the pump on a 24-hour basal delivery program with no intermittent power reboots.The returned battery cap was able to tighten to the returned pump and to the test pump.Additionally, investigation revealed evidence of moisture in the battery compartment, underside the returned battery cap, and behind the display lens.A leak test was performed and failed due to a battery compartment leak.The pump was opened up and evidence of moisture was found throughout the internal pump components and on the main printed circuit board.No damages were noted to the power circuit.Unrelated to the original complaint, the battery compartment was noted to be cracked in two places.In addition, the pump casing and the cartridge compartment were observed to be cracked.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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On (b)(6) 2016, the reporter contacted animas, alleging a power (moisture ingress) issue.The reporter alleged intermittent power issue.In addition, it was reported that there was moisture behind the display.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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