On (b)(6) 2016, the reporter contacted animas, alleging a prime (loss of prime) issue.It was reported that the pump repeatedly emitted loss of prime warnings despite cartridge changes.There was no indication that the product caused or contributed to an adverse event.This issue is being reported because it may result in a long term cessation of insulin delivery if the user is unable to resolve the alarm.
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The device has been returned and evaluated by product analysis on 01/13/2017 with the following findings: a review of the black box data from the date of the complaint was overwritten.The current black box showed multiple loss of prime warnings with low non zero force.The rewind, load, and prime steps were performed successfully.The pump was exercised for 24 hours and the loss of prime complaint was not duplicated.Force calibration testing passed.Unrelated to the original complaint, the battery compartment was cracked at the threads to the left side of the grip pad down to the seal, and form the case seal to the grip pad.
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