On (b)(6) 2016, the reporter contacted animas, alleging a history/settings (history/settings issue) issue.Reportedly, the insulin on board would read zero after performing the rewind, load, and prime steps for a cartridge change even if there was insulin on board.The patient's healthcare provider reportedly insisted the pump be replaced.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported as an issue with the pump not performing as intended with regards to the history or the settings may result in over or under delivery.
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Follow-up #1: date of submission 10/20/2016 device evaluation: the device has been returned and evaluated by product analysis on 09/26/2016 with the following findings: pump boots to verify screen with audible and vibratory features.Ezprime sequence was successfully completed.Successfully performed a 10u audio and 10u normal bolus.Both were accurately recorded in the pump history.The iob correctly showed 20u.A full rewind, load and prime sequence were then performed to simulate a cartridge change; the iob did not reset to zero.The iob correctly showed 20u.Unable to duplicate the complaint.Unrelated to the complaint, battery compartment is cracked above and below the bumper pad.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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