On (b)(6) 2016, the reporter contacted animas, alleging a power (intermittent power) issue.Reportedly, the yellow o-ring was not visible at the battery cap.The reporter denied any damage to the battery compartment.In addition, reportedly, there was no moisture in the pump.The reporter stated that the correct battery type was used; however, when the reporter changed the battery, the intermittent power issue remained unresolved.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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Follow-up #1: date of submission 05/17/2016.Device evaluation: the device has been returned and evaluated by product analysis on 04/29/2016 with the following findings: product evaluation was conducted and the alleged complaint could not be duplicated.The review of the black box data showed unexplained power reboots; however, the power issue was not duplicated during the actual testing.The battery compartment and the battery cap were undamaged and the cap was able to fit securely to maintain electrical connection.The battery cap contact height and width measurements were within specifications.Additionally, the battery cap was fastened and then unscrewed half turn with no reboots occurring.The ez-prime steps were performed correctly with no power interruptions or any errors, alarms or warnings.Upon pump cover removal, no intermittent condition was found to the continuous glucose monitoring module or to the power circuit board.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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